Trial Outcomes & Findings for An Innovative Intervention for OUD Treatment (NCT NCT04325659)
NCT ID: NCT04325659
Last Updated: 2026-06-09
Results Overview
The number of participants retained (dichotomous: retained, not retained) during the 5 day intervention. Greater retention is indicative of a better treatment outcome.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
36 participants
Primary outcome timeframe
Up to 5 days
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
Active Bridge Device/ Placebo Study Drug
Active Bridge Device and placebo study drug
|
Lofexidine/Sham Bridge Device
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
Inactive Bridge Device and placebo study drug
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
6
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Innovative Intervention for OUD Treatment
Baseline characteristics by cohort
| Measure |
Lofexidine/Sham Bridge Device
n=7 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=8 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=6 Participants
Active Bridge Device and placebo study drug
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
21 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
18 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
12 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 5 daysThe number of participants retained (dichotomous: retained, not retained) during the 5 day intervention. Greater retention is indicative of a better treatment outcome.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Number of Participants Retained
|
7 Participants
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: At the end of day 5Peak COWS Score (range: 0-48). Lower peak COWS scores are indicative of better withdrawal suppression.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Withdrawal Severity as Measured by Clinical Opiate Withdrawal Scale (COWS) Peak Score
|
10.5 score on a scale
Standard Deviation 5.3
|
9.2 score on a scale
Standard Deviation 5.0
|
11.4 score on a scale
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Four times a day (0800, 1200, 1600, 2000) on each of days 1-5Area under the curve COWS scores (range: 0-240). Smaller area under the curve COWS scores are indicative of better withdrawal suppression.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Withdrawal Severity as Measured by Area Under the Curve for COWS Score From Days 1-5 of Active Study Intervention
|
34.0 scores on a scale*day
Standard Deviation 5.6
|
28.5 scores on a scale*day
Standard Deviation 4.8
|
26.6 scores on a scale*day
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: Up to 5 daysPeak daily COWS score (range: 0-48). Lower peak daily COWS scores are indicative of better withdrawal suppression.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Withdrawal Severity as Measured by COWS Peak Daily Score
Day 3
|
8.8 COWS Total Daily Peak Score
Standard Deviation 4.6
|
7.2 COWS Total Daily Peak Score
Standard Deviation 3.3
|
6.0 COWS Total Daily Peak Score
Standard Deviation 2.8
|
|
Withdrawal Severity as Measured by COWS Peak Daily Score
Day 4
|
8.0 COWS Total Daily Peak Score
Standard Deviation 5.0
|
5.7 COWS Total Daily Peak Score
Standard Deviation 2.7
|
6.0 COWS Total Daily Peak Score
Standard Deviation 3.8
|
|
Withdrawal Severity as Measured by COWS Peak Daily Score
Day 5
|
5.6 COWS Total Daily Peak Score
Standard Deviation 2.1
|
5.7 COWS Total Daily Peak Score
Standard Deviation 3.8
|
4.0 COWS Total Daily Peak Score
Standard Deviation 2.9
|
|
Withdrawal Severity as Measured by COWS Peak Daily Score
Day 1
|
8.5 COWS Total Daily Peak Score
Standard Deviation 3.8
|
7.8 COWS Total Daily Peak Score
Standard Deviation 3.6
|
9.3 COWS Total Daily Peak Score
Standard Deviation 5.6
|
|
Withdrawal Severity as Measured by COWS Peak Daily Score
Day 2
|
10.2 COWS Total Daily Peak Score
Standard Deviation 2.8
|
8.9 COWS Total Daily Peak Score
Standard Deviation 3.8
|
9.3 COWS Total Daily Peak Score
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: At the end of day 9The number of participants who are retained (dichotomous: retained, not retained) during the 9 day intervention. Greater retention is indicative of better intervention outcome.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Number of Participants Retained
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to day 5Peak SOWS Score (range: 0-64). Lower peak SOWS scores are indicative of better withdrawal suppression.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Withdrawal Severity as Measured by the SOWS Peak Daily Score
Day 1
|
22.8 Peak Daily Score
Standard Deviation 18.9
|
10.6 Peak Daily Score
Standard Deviation 7.7
|
16.0 Peak Daily Score
Standard Deviation 11.6
|
|
Withdrawal Severity as Measured by the SOWS Peak Daily Score
Day 2
|
18.6 Peak Daily Score
Standard Deviation 11.9
|
15.6 Peak Daily Score
Standard Deviation 13.3
|
22.2 Peak Daily Score
Standard Deviation 23.1
|
|
Withdrawal Severity as Measured by the SOWS Peak Daily Score
Day 3
|
22.7 Peak Daily Score
Standard Deviation 20.1
|
16.1 Peak Daily Score
Standard Deviation 19.6
|
10.6 Peak Daily Score
Standard Deviation 6.7
|
|
Withdrawal Severity as Measured by the SOWS Peak Daily Score
Day 4
|
19.5 Peak Daily Score
Standard Deviation 21.2
|
8.3 Peak Daily Score
Standard Deviation 11.3
|
9.9 Peak Daily Score
Standard Deviation 10.0
|
|
Withdrawal Severity as Measured by the SOWS Peak Daily Score
Day 5
|
15.1 Peak Daily Score
Standard Deviation 14.5
|
8.1 Peak Daily Score
Standard Deviation 11.9
|
10.4 Peak Daily Score
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Four times a day (0800, 1200, 1600, 2000) days 1-5Area under the curve SOWS scores (range: 0-320). Smaller area under the curve SOWS scores are indicative of better withdrawal suppression.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Withdrawal Severity as Measured by Area Under the Curve SOWS Score
|
79.7 Scores on a scale*day
Standard Deviation 25.3
|
49.4 Scores on a scale*day
Standard Deviation 19.9
|
55.8 Scores on a scale*day
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: End of Day 5Peak daily SOWS score (range: 0-64). Lower peak daily SOWS scores are indicative of better withdrawal suppression.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Withdrawal Severity as Measured by the Subjective Opiate Withdrawal Scale (SOWS) Peak Score
|
28.7 peak daily score
Standard Deviation 21.6
|
18.2 peak daily score
Standard Deviation 17.0
|
27.4 peak daily score
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: At the end of day 9The number of participants who initiate naltrexone (dichotomous: yes, no) at the end of day 9. A larger number of participants is indicative of better naltrexone initiation success.
Outcome measures
| Measure |
Lofexidine/Sham Bridge Device
n=12 Participants
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 Participants
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 Participants
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Number of Participants Who Initiate Naltrexone at the End of the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 daysNumber of concomitant medications used per day. A smaller number of concomitant medications used per day is indicative of better treatment efficacy.
Outcome measures
Outcome data not reported
Adverse Events
Lofexidine/Sham Bridge Device
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Sham Bridge Device /Placebo Study Drug
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Active Bridge Device/ Placebo Study Drug
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lofexidine/Sham Bridge Device
n=12 participants at risk
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 participants at risk
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 participants at risk
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Psychiatric disorders
Agitation
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
Other adverse events
| Measure |
Lofexidine/Sham Bridge Device
n=12 participants at risk
Lofexidine (Lucemyra) encapsulated with inactive Bridge Device
|
Sham Bridge Device /Placebo Study Drug
n=12 participants at risk
Inactive Bridge Device and placebo study drug
|
Active Bridge Device/ Placebo Study Drug
n=12 participants at risk
Active Bridge Device and placebo study drug
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
16.7%
2/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Cardiac disorders
Abnormal ECG
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
16.7%
2/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Nervous system disorders
Pain (including headache)
|
25.0%
3/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
16.7%
2/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Cardiac disorders
Elevated blood pressure
|
25.0%
3/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
41.7%
5/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
50.0%
6/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Cardiac disorders
Low blood pressure
|
25.0%
3/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
25.0%
3/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
33.3%
4/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
16.7%
2/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
16.7%
2/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
16.7%
2/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
0.00%
0/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
8.3%
1/12 • From the time of randomization up to day 9 (the end of the participant's residential stay)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place