Trial Outcomes & Findings for Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD (NCT NCT04316559)
NCT ID: NCT04316559
Last Updated: 2026-06-02
Results Overview
The subjective opioid withdrawal scale (SOWS) is a widely used measure for evaluating the intensity of opioid withdrawal symptoms. It consists of 16 items (such as "I feel nauseated" and "I am shaking"), each rated by participants on a 5-point scale of intensity from 0 (not at all) to 4 (extremely). The score is a sum of all item ratings; scores can range from 0 to 64, with standard cutoffs for mild withdrawal (1-10), moderate withdrawal (11-20), and severe withdrawal (21 or higher). Higher score indicates more severe withdrawal. Measurements were taken up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to four hours during each session, for a total of five noncontiguous session days
Results posted on
2026-06-02
Participant Flow
Participant milestones
| Measure |
Opioid Withdrawal Suppression Interventions: Oxycodone, Then Placebo
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive a single dose of oxycodone 30mg orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
Opioid Withdrawal Suppression Interventions: Placebo, Then Oxycodone
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|---|
|
Pilot: Crossover Session 1
STARTED
|
4
|
1
|
|
Pilot: Crossover Session 1
COMPLETED
|
4
|
1
|
|
Pilot: Crossover Session 1
NOT COMPLETED
|
0
|
0
|
|
Pilot: Crossover Session 2
STARTED
|
4
|
1
|
|
Pilot: Crossover Session 2
COMPLETED
|
4
|
1
|
|
Pilot: Crossover Session 2
NOT COMPLETED
|
0
|
0
|
|
Pilot: Per Dose Level Sessions 3-5
STARTED
|
4
|
1
|
|
Pilot: Per Dose Level Sessions 3-5
TRV734 65mg
|
1
|
0
|
|
Pilot: Per Dose Level Sessions 3-5
TRV734 75mg
|
1
|
0
|
|
Pilot: Per Dose Level Sessions 3-5
TRV734 90mg
|
4
|
0
|
|
Pilot: Per Dose Level Sessions 3-5
TRV734 105mg
|
2
|
0
|
|
Pilot: Per Dose Level Sessions 3-5
TRV734 125mg
|
2
|
0
|
|
Pilot: Per Dose Level Sessions 3-5
TRV734 175mg
|
1
|
1
|
|
Pilot: Per Dose Level Sessions 3-5
COMPLETED
|
3
|
0
|
|
Pilot: Per Dose Level Sessions 3-5
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Opioid Withdrawal Suppression Interventions: Oxycodone, Then Placebo
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive a single dose of oxycodone 30mg orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
Opioid Withdrawal Suppression Interventions: Placebo, Then Oxycodone
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
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|---|---|---|
|
Pilot: Per Dose Level Sessions 3-5
Withdrawal by Subject
|
1
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0
|
|
Pilot: Per Dose Level Sessions 3-5
Pandemic shutdown
|
0
|
1
|
Baseline Characteristics
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
Baseline characteristics by cohort
| Measure |
Overall Study Participants
n=5 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to four hours during each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
The subjective opioid withdrawal scale (SOWS) is a widely used measure for evaluating the intensity of opioid withdrawal symptoms. It consists of 16 items (such as "I feel nauseated" and "I am shaking"), each rated by participants on a 5-point scale of intensity from 0 (not at all) to 4 (extremely). The score is a sum of all item ratings; scores can range from 0 to 64, with standard cutoffs for mild withdrawal (1-10), moderate withdrawal (11-20), and severe withdrawal (21 or higher). Higher score indicates more severe withdrawal. Measurements were taken up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
Placebo
|
6.46 units on a scale
Interval 5.5 to 7.51
|
|
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
Oxycodone 30 mg
|
5.93 units on a scale
Interval 4.7 to 7.32
|
|
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
TRV734_65mg
|
12.68 units on a scale
Interval 9.81 to 15.65
|
|
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
TRV734_75mg
|
9.49 units on a scale
Interval 7.13 to 12.01
|
|
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
TRV734_90mg
|
2.28 units on a scale
Interval 1.71 to 2.93
|
|
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
TRV734_105mg
|
4.11 units on a scale
Interval 3.13 to 5.28
|
|
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
TRV734_125mg
|
2.93 units on a scale
Interval 1.88 to 4.24
|
|
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
TRV734_175mg
|
3.56 units on a scale
Interval 1.93 to 5.26
|
SECONDARY outcome
Timeframe: Session baseline and up to four hours during each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in binomial regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
The clinical opioid withdrawal scale (COWS) is a widely used measure for evaluating the intensity of both signs and symptoms of opioid withdrawal. Signs are assessed by an observed; symptoms are assessed by asking the participant to rate them. Each of 11 COWS items item is scored on a 3, 4, or 5 point scale to reflect the severity of the symptom, with a maximum score of 48. Standard cutoffs are: mild withdrawal (5-12), moderate withdrawal (13-24), moderately severe withdrawal (25-36), and severe withdrawal (36 or higher). Higher score indicates more severe withdrawal. Measurements were taken up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with binomial regression to estimate probability of moderate withdrawal (versus mild withdrawal) with 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Withdrawal Signs Assessed by the Clinical Opioid Withdrawal Scale (COWS)
TRV734_75mg
|
0.17 Proportion probability
Interval 0.01 to 0.8
|
|
Withdrawal Signs Assessed by the Clinical Opioid Withdrawal Scale (COWS)
Oxycodone 30mg
|
0.11 Proportion probability
Interval 0.01 to 0.68
|
|
Withdrawal Signs Assessed by the Clinical Opioid Withdrawal Scale (COWS)
Placebo
|
0.20 Proportion probability
Interval 0.02 to 0.82
|
|
Withdrawal Signs Assessed by the Clinical Opioid Withdrawal Scale (COWS)
TRV734_65mg
|
0.66 Proportion probability
Interval 0.1 to 0.98
|
|
Withdrawal Signs Assessed by the Clinical Opioid Withdrawal Scale (COWS)
TRV734_90mg
|
0.02 Proportion probability
Interval 0.0 to 0.32
|
|
Withdrawal Signs Assessed by the Clinical Opioid Withdrawal Scale (COWS)
TRV734_105mg
|
0.04 Proportion probability
Interval 0.0 to 0.47
|
|
Withdrawal Signs Assessed by the Clinical Opioid Withdrawal Scale (COWS)
TRV734_125mg
|
0.07 Proportion probability
Interval 0.0 to 0.64
|
|
Withdrawal Signs Assessed by the Clinical Opioid Withdrawal Scale (COWS)
TRV734_175mg
|
0.10 Proportion probability
Interval 0.0 to 0.76
|
SECONDARY outcome
Timeframe: Session baseline and up to four hours during each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
Pupil diameter is a commonly used indicator of opioid withdrawal; wider diameters suggest more severe withdrawal, though there are no specific cutoffs, and clinical judgment must be used to assess pupil diameter relative to ambient light. Measurements were taken with a pupillometer up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Withdrawal Signs Assessed by Pupil Diameter
TRV734_65mg
|
4.44 millimeter (mm)
Interval 3.63 to 5.15
|
|
Withdrawal Signs Assessed by Pupil Diameter
TRV734_75mg
|
3.82 millimeter (mm)
Interval 3.02 to 4.55
|
|
Withdrawal Signs Assessed by Pupil Diameter
Oxycodone 30 mg
|
4.43 millimeter (mm)
Interval 3.72 to 5.15
|
|
Withdrawal Signs Assessed by Pupil Diameter
Placebo
|
4.62 millimeter (mm)
Interval 3.91 to 5.35
|
|
Withdrawal Signs Assessed by Pupil Diameter
TRV734_90mg
|
4.23 millimeter (mm)
Interval 3.53 to 4.96
|
|
Withdrawal Signs Assessed by Pupil Diameter
TRV734_105mg
|
4.29 millimeter (mm)
Interval 3.61 to 5.07
|
|
Withdrawal Signs Assessed by Pupil Diameter
TRV734_125mg
|
4.15 millimeter (mm)
Interval 3.4 to 4.88
|
|
Withdrawal Signs Assessed by Pupil Diameter
TRV734_175mg
|
4.58 millimeter (mm)
Interval 3.77 to 5.31
|
SECONDARY outcome
Timeframe: Session baseline and up to four hours after each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
The Four-Choice Reaction-Time task was one of two tasks used to assess psychomotor performance; this outcome measure was one of two main measures derived from the task. Participants performed the task on a laptop computer, and task response time was measured in milliseconds. Measurements were taken once per hour, up to four hours after each treatment. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Psychomotor Performance: Response Time in Four-Choice Reaction-Time Task
TRV734_105mg
|
502.7 millisecond (ms)
Interval 485.2 to 520.4
|
|
Psychomotor Performance: Response Time in Four-Choice Reaction-Time Task
TRV734_75mg
|
387.4 millisecond (ms)
Interval 362.6 to 412.3
|
|
Psychomotor Performance: Response Time in Four-Choice Reaction-Time Task
Oxycodone 30 mg
|
485.9 millisecond (ms)
Interval 473.6 to 498.4
|
|
Psychomotor Performance: Response Time in Four-Choice Reaction-Time Task
Placebo
|
476.4 millisecond (ms)
Interval 464.0 to 488.6
|
|
Psychomotor Performance: Response Time in Four-Choice Reaction-Time Task
TRV734_65mg
|
392.3 millisecond (ms)
Interval 367.3 to 417.6
|
|
Psychomotor Performance: Response Time in Four-Choice Reaction-Time Task
TRV734_90mg
|
467.9 millisecond (ms)
Interval 455.2 to 480.5
|
|
Psychomotor Performance: Response Time in Four-Choice Reaction-Time Task
TRV734_125mg
|
493.6 millisecond (ms)
Interval 475.8 to 511.2
|
|
Psychomotor Performance: Response Time in Four-Choice Reaction-Time Task
TRV734_175mg
|
442.3 millisecond (ms)
Interval 417.5 to 467.0
|
SECONDARY outcome
Timeframe: Session baseline and up to four hours after each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
The Four-Choice Reaction-Time task was one of two tasks used to assess psychomotor performance; this outcome measure was the second of two main measures derived from the task. Participants performed the task on a laptop computer, and proportion of correct responses was assessed. Measurements were taken once per hour, up to four hours after each treatment. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Psychomotor Performance: Proportion of Correct Responses in Four-Choice Reaction-Time Task
TRV734_105mg
|
0.927 Proportion of correct response
Interval 0.884 to 0.952
|
|
Psychomotor Performance: Proportion of Correct Responses in Four-Choice Reaction-Time Task
Oxycodone 30 mg
|
0.962 Proportion of correct response
Interval 0.939 to 0.974
|
|
Psychomotor Performance: Proportion of Correct Responses in Four-Choice Reaction-Time Task
Placebo
|
0.944 Proportion of correct response
Interval 0.913 to 0.96
|
|
Psychomotor Performance: Proportion of Correct Responses in Four-Choice Reaction-Time Task
TRV734_65mg
|
0.947 Proportion of correct response
Interval 0.905 to 0.974
|
|
Psychomotor Performance: Proportion of Correct Responses in Four-Choice Reaction-Time Task
TRV734_75mg
|
0.944 Proportion of correct response
Interval 0.901 to 0.973
|
|
Psychomotor Performance: Proportion of Correct Responses in Four-Choice Reaction-Time Task
TRV734_90mg
|
0.938 Proportion of correct response
Interval 0.905 to 0.955
|
|
Psychomotor Performance: Proportion of Correct Responses in Four-Choice Reaction-Time Task
TRV734_125mg
|
0.931 Proportion of correct response
Interval 0.89 to 0.954
|
|
Psychomotor Performance: Proportion of Correct Responses in Four-Choice Reaction-Time Task
TRV734_175mg
|
0.938 Proportion of correct response
Interval 0.887 to 0.97
|
SECONDARY outcome
Timeframe: Session baseline and up to four hours after each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
The Number-Vigilance test was used to assess psychomotor performance, specifically sustained attention and reaction time. Participants performed the task on a computer, responding when the number on the screen changed. Measurements were taken once per hour, up to four hours after each treatment. Sensitivity index was calculated by the testing software as the standardized difference between the hit rate (correct detection of the stimulus change) and the false alarm rate (incorrect responding in the absence of a stimulus change). Higher scores indicate better performance, with 0 indicating performance no better than chance and values over 3 indicating near perfect performance. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Psychomotor Performance: d-Prime (an Accuracy Measure) in Number-Vigilance Test
TRV734_175mg
|
5.06 d-Prime
Interval 4.52 to 5.59
|
|
Psychomotor Performance: d-Prime (an Accuracy Measure) in Number-Vigilance Test
Oxycodone 30 mg
|
4.39 d-Prime
Interval 4.12 to 4.66
|
|
Psychomotor Performance: d-Prime (an Accuracy Measure) in Number-Vigilance Test
Placebo
|
4.39 d-Prime
Interval 4.13 to 4.65
|
|
Psychomotor Performance: d-Prime (an Accuracy Measure) in Number-Vigilance Test
TRV734_65mg
|
3.87 d-Prime
Interval 3.34 to 4.4
|
|
Psychomotor Performance: d-Prime (an Accuracy Measure) in Number-Vigilance Test
TRV734_75mg
|
4.67 d-Prime
Interval 4.14 to 5.21
|
|
Psychomotor Performance: d-Prime (an Accuracy Measure) in Number-Vigilance Test
TRV734_90mg
|
4.29 d-Prime
Interval 4.02 to 4.56
|
|
Psychomotor Performance: d-Prime (an Accuracy Measure) in Number-Vigilance Test
TRV734_105mg
|
3.84 d-Prime
Interval 3.46 to 4.23
|
|
Psychomotor Performance: d-Prime (an Accuracy Measure) in Number-Vigilance Test
TRV734_125mg
|
4.38 d-Prime
Interval 4.01 to 4.76
|
SECONDARY outcome
Timeframe: Up to four hours during each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
This item on a Visual Analog Scale (VAS) was a participant self-rating of perceived bad effects from the the study pill. The prompt was "Do you feel any bad effects from the study pill?"; the response scale was a 100-mm horizontal line on which the participant marked a point at or between two labeled extremes: 0 ("Not at all or never had any") and 100 ("Extremely"). Measurements were taken up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Visual Analog Scales (VAS): Perceived Bad Effects From Study Drug
TRV734_90mg
|
2.16 units on a scale
Interval 0.93 to 4.58
|
|
Visual Analog Scales (VAS): Perceived Bad Effects From Study Drug
Oxycodone 30 mg
|
4.12 units on a scale
Interval 2.11 to 7.0
|
|
Visual Analog Scales (VAS): Perceived Bad Effects From Study Drug
Placebo
|
0.99 units on a scale
Interval 0.18 to 2.89
|
|
Visual Analog Scales (VAS): Perceived Bad Effects From Study Drug
TRV734_65mg
|
18.32 units on a scale
Interval 3.97 to 63.32
|
|
Visual Analog Scales (VAS): Perceived Bad Effects From Study Drug
TRV734_75mg
|
0.39 units on a scale
Interval 0.0 to 36.52
|
|
Visual Analog Scales (VAS): Perceived Bad Effects From Study Drug
TRV734_105mg
|
0.02 units on a scale
Interval 0.0 to 19.16
|
|
Visual Analog Scales (VAS): Perceived Bad Effects From Study Drug
TRV734_125mg
|
1.21 units on a scale
Interval 0.02 to 26.26
|
|
Visual Analog Scales (VAS): Perceived Bad Effects From Study Drug
TRV734_175mg
|
0.78 units on a scale
Interval 0.0 to 39.6
|
SECONDARY outcome
Timeframe: Session baseline and up to four hours during each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
This item on a Visual Analog Scale (VAS) was a participant self-rating of severity of opioid craving. The prompt was a "Do you crave more opioids (like heroin or oxycodone) right now?"; the response scale was 100-mm horizontal line on which the participant marked a point at or between two labeled extremes: 0 ("Not at all") and 100 ("Extremely"). Measurements were taken up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Visual Analog Scales (VAS): Opioid Craving
TRV734_65mg
|
47.35 units on a scale
Interval 19.97 to 83.06
|
|
Visual Analog Scales (VAS): Opioid Craving
Oxycodone 30 mg
|
23.47 units on a scale
Interval 20.51 to 26.43
|
|
Visual Analog Scales (VAS): Opioid Craving
Placebo
|
38.46 units on a scale
Interval 35.35 to 41.61
|
|
Visual Analog Scales (VAS): Opioid Craving
TRV734_75mg
|
45.92 units on a scale
Interval 18.99 to 81.07
|
|
Visual Analog Scales (VAS): Opioid Craving
TRV734_90mg
|
13.27 units on a scale
Interval 10.54 to 16.56
|
|
Visual Analog Scales (VAS): Opioid Craving
TRV734_105mg
|
36.43 units on a scale
Interval 20.84 to 64.54
|
|
Visual Analog Scales (VAS): Opioid Craving
TRV734_125mg
|
17.86 units on a scale
Interval 2.3 to 41.22
|
|
Visual Analog Scales (VAS): Opioid Craving
TRV734_175mg
|
15.66 units on a scale
Interval 0.01 to 60.68
|
SECONDARY outcome
Timeframe: Session baseline and up to four hours during each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
This item on a Visual Analog Scale (VAS) was a participant self-rating of severity of opioid withdrawal symptoms, intended to complement the score from the multi-item SOWS. The prompt was "Are you feeling withdrawal symptoms right now?"; the response scale was a 100-mm horizontal line on which the participant marked a point at or between two labeled extremes: 0 ("Not at all") and 100 ("Extremely"). Measurements were taken up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Visual Analog Scales (VAS): Global Self-rating of Opioid Withdrawal Symptoms
TRV734_105mg
|
42.98 units on a scale
Interval 23.63 to 71.74
|
|
Visual Analog Scales (VAS): Global Self-rating of Opioid Withdrawal Symptoms
Oxycodone 30 mg
|
23.08 units on a scale
Interval 19.88 to 26.58
|
|
Visual Analog Scales (VAS): Global Self-rating of Opioid Withdrawal Symptoms
Placebo
|
41.28 units on a scale
Interval 37.65 to 45.19
|
|
Visual Analog Scales (VAS): Global Self-rating of Opioid Withdrawal Symptoms
TRV734_65mg
|
51.54 units on a scale
Interval 22.81 to 89.5
|
|
Visual Analog Scales (VAS): Global Self-rating of Opioid Withdrawal Symptoms
TRV734_75mg
|
51.23 units on a scale
Interval 22.01 to 89.87
|
|
Visual Analog Scales (VAS): Global Self-rating of Opioid Withdrawal Symptoms
TRV734_90mg
|
20.80 units on a scale
Interval 17.71 to 24.05
|
|
Visual Analog Scales (VAS): Global Self-rating of Opioid Withdrawal Symptoms
TRV734_125mg
|
33.36 units on a scale
Interval 10.61 to 48.96
|
|
Visual Analog Scales (VAS): Global Self-rating of Opioid Withdrawal Symptoms
TRV734_175mg
|
32.31 units on a scale
Interval 4.17 to 62.77
|
SECONDARY outcome
Timeframe: Up to four hours during each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
This item on a Visual Analog Scale (VAS) was a participant self-rating of perceived high from the the study pill. The prompt was "Do you feel high from the study pill?"; the response scale was a 100-mm horizontal line on which the participant marked a point at or between two labeled extremes: 0 ("Not at all or never had any") and 100 ("Extremely"). Measurements were taken up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Visual Analog Scales (VAS): Perceived High From Study Drug
Oxycodone 30 mg
|
2.07 units on a scale
Interval 0.9 to 5.41
|
|
Visual Analog Scales (VAS): Perceived High From Study Drug
Placebo
|
0.13 units on a scale
Interval 0.02 to 0.72
|
|
Visual Analog Scales (VAS): Perceived High From Study Drug
TRV734_65mg
|
0.15 units on a scale
Interval 0.0 to 25.3
|
|
Visual Analog Scales (VAS): Perceived High From Study Drug
TRV734_75mg
|
0.21 units on a scale
Interval 0.0 to 27.06
|
|
Visual Analog Scales (VAS): Perceived High From Study Drug
TRV734_90mg
|
0.00 units on a scale
Interval 0.0 to 0.44
|
|
Visual Analog Scales (VAS): Perceived High From Study Drug
TRV734_105mg
|
0.01 units on a scale
Interval 0.0 to 8.81
|
|
Visual Analog Scales (VAS): Perceived High From Study Drug
TRV734_125mg
|
0.01 units on a scale
Interval 0.0 to 8.35
|
|
Visual Analog Scales (VAS): Perceived High From Study Drug
TRV734_175mg
|
0.03 units on a scale
Interval 0.0 to 20.17
|
SECONDARY outcome
Timeframe: Up to four hours after each session, for a total of five noncontiguous session daysPopulation: All analyzed participants data used in Bayesian multilevel regression to estimate values reported, therefore, all analyzed participants contributed to each row's data. There were no usable data for one participant because participant did not have symptoms of methadone withdrawal.
This item on a Visual Analog Scale (VAS) was a participant self-rating of perceived withdrawal relief attributed to the study pill. The prompt was "Is the study pill relieving your withdrawal symptoms?"; the response scale was a 100-mm horizontal line on which the participant marked a point at or between two labeled extremes: 0 ("Not at all or never had any") and 100 ("Completely"). Measurements were taken up to four hours during each study session--every 15 minutes for the first hour, decreasing to every 30 minutes as the session progressed. Analysis was done with Bayesian multilevel regression, to estimate marginal means and a 95% credible interval (CI) for each treatment as estimated by the regression.
Outcome measures
| Measure |
Opioid Withdrawal Suppression Interventions
n=4 Participants
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|
|
Visual Analog Scales (VAS): Perceived Relief of Opioid Withdrawal Symptoms by Study Drug
TRV734_65mg
|
30.56 units on a scale
Interval 5.84 to 67.17
|
|
Visual Analog Scales (VAS): Perceived Relief of Opioid Withdrawal Symptoms by Study Drug
Oxycodone 30 mg
|
67.45 units on a scale
Interval 62.95 to 71.81
|
|
Visual Analog Scales (VAS): Perceived Relief of Opioid Withdrawal Symptoms by Study Drug
Placebo
|
48.29 units on a scale
Interval 43.92 to 53.03
|
|
Visual Analog Scales (VAS): Perceived Relief of Opioid Withdrawal Symptoms by Study Drug
TRV734_75mg
|
39.39 units on a scale
Interval 10.37 to 72.51
|
|
Visual Analog Scales (VAS): Perceived Relief of Opioid Withdrawal Symptoms by Study Drug
TRV734_90mg
|
71.59 units on a scale
Interval 67.64 to 75.36
|
|
Visual Analog Scales (VAS): Perceived Relief of Opioid Withdrawal Symptoms by Study Drug
TRV734_105mg
|
54.39 units on a scale
Interval 26.28 to 71.29
|
|
Visual Analog Scales (VAS): Perceived Relief of Opioid Withdrawal Symptoms by Study Drug
TRV734_125mg
|
70.39 units on a scale
Interval 53.23 to 90.0
|
|
Visual Analog Scales (VAS): Perceived Relief of Opioid Withdrawal Symptoms by Study Drug
TRV734_175mg
|
65.13 units on a scale
Interval 33.21 to 93.95
|
Adverse Events
Oxycodone 30mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TRV734 65mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TRV734 75mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TRV734 90mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TRV734 105mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TRV734 125mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TRV734 175mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Overall Study
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxycodone 30mg
n=5 participants at risk
Participants received a single dose of oxycodone 30mg orally.
|
Placebo
n=5 participants at risk
Participants received a single dose of Placebo orally.
|
TRV734 65mg
n=1 participants at risk
Participants received the investigational drug TRV734 75mg orally once on session day.
|
TRV734 75mg
n=1 participants at risk
Participants received the investigational drug TRV734 75mg orally once on session day.
|
TRV734 90mg
n=4 participants at risk
Participants received the investigational drug TRV734 90mg orally once on session day.
|
TRV734 105mg
n=2 participants at risk
Participants received the investigational drug TRV734 105mg orally once on session day.
|
TRV734 125mg
n=2 participants at risk
Participants received the investigational drug TRV734 125mg orally once on session day.
|
TRV734 175mg
n=2 participants at risk
Participants received the investigational drug TRV734 175mg orally once on session day.
|
Overall Study
n=5 participants at risk
There were 5 noncontiguous session days, each conducted when the participant was in a state of mild to moderate withdrawal from methadone. All participants received oxycodone, placebo, and varying doses of the investigational drug TRV734.
On session day 1, participants were randomized to receive either a single dose of oxycodone 30mg orally or a single dose of placebo orally.
On session day 2, participants received whichever of the two interventions (oxycodone 30mg, or placebo) they had not received on day 1.
On session days 3 to 5, participants received the investigational drug TRV734, orally, once per session day, starting with a dose intended to be minimally but detectably effective for withdrawal relief, and adjusted higher or lower on subsequent session days to identify partly effective and fully effective doses; dose for each session ranged from 65 to 175mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Oedema peripheral
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
25.0%
1/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
General disorders
Asthenia
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
General disorders
Fatigue
|
40.0%
2/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
25.0%
1/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
50.0%
1/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
40.0%
2/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
General disorders
Feeling of relaxation
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
General disorders
Flushing
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
40.0%
2/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
General disorders
Hyperhidrosis
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
40.0%
2/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
General disorders
Vascular access site bruising
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
25.0%
1/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
General disorders
Vascular access site oedema
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Investigations
White blood cell count increased
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
25.0%
1/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Nervous system disorders
Paraesthesia
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Nervous system disorders
Somnolence
|
40.0%
2/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
25.0%
1/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
50.0%
1/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
40.0%
2/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
25.0%
1/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
50.0%
1/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
40.0%
2/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
50.0%
1/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Psychiatric disorders
Tearfulness
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
25.0%
1/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
50.0%
1/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Vascular disorders
Ecchymosis
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/1 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/4 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
0.00%
0/2 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
20.0%
1/5 • Duration of inpatient admission, up to 30 days while on the study
Adverse events associated with methadone withdrawal have been grouped under "overall study".
|
Additional Information
Dr. David Epstein
National Institute on Drug Abuse (NIDA)
Phone: 667-312-5092
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place