Trial Outcomes & Findings for A Novel Human Lab Model for Screening AUD Medications (NCT NCT04249882)
NCT ID: NCT04249882
Last Updated: 2023-09-14
Results Overview
The percentage of days abstinent from alcohol is determined using the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the percent of days participants were abstinent during the practice quit period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
6 days
Results posted on
2023-09-14
Participant Flow
Participants were recruited via online and print advertisements, local bus campaigns, and targeted recruitment through a laboratory database of previous study participants who agreed to be contacted for further studies.
A stratified randomization list was developed by a statistician and was based on gender, smoking status (as reported on the Fagerstrom Test for Nicotine Dependence (FTND; (Heatherton et al. 1991)), and drinking status ('heavy' drinker defined as ≥ 14 for males/ ≥7 for females, or 'very heavy' drinker defined as ≥35 for males/≥ 28 for females).
Participant milestones
| Measure |
Placebo
Matched to active medications
Placebo: Matched to active medication
|
Varenicline
1 mg twice a day
Varenicline: 1 mg twice a day
|
Naltrexone
50 mg once a day
Naltrexone: 50 mg once a day
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
15
|
|
Overall Study
COMPLETED
|
17
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Novel Human Lab Model for Screening AUD Medications
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
Matched to active medications
Placebo: Matched to active medication
|
Varenicline
n=19 Participants
1 mg twice a day
Varenicline: 1 mg twice a day
|
Naltrexone
n=15 Participants
50 mg once a day
Naltrexone: 50 mg once a day
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.47 years
STANDARD_DEVIATION 11.91 • n=99 Participants
|
41.84 years
STANDARD_DEVIATION 13.04 • n=107 Participants
|
42.40 years
STANDARD_DEVIATION 11.19 • n=206 Participants
|
41.87 years
STANDARD_DEVIATION 11.91 • n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
15 participants
n=206 Participants
|
53 participants
n=7 Participants
|
|
Last 30 Days Drinks Per Drinking Day
|
5.46 number of drinks per drinking day
STANDARD_DEVIATION 2.39 • n=99 Participants
|
5.84 number of drinks per drinking day
STANDARD_DEVIATION 3.68 • n=107 Participants
|
5.89 number of drinks per drinking day
STANDARD_DEVIATION 3.48 • n=206 Participants
|
5.73 number of drinks per drinking day
STANDARD_DEVIATION 3.18 • n=7 Participants
|
|
Past Month Percent Day Abstinent
|
25.79 percent days abstinent
STANDARD_DEVIATION 21.16 • n=99 Participants
|
28.78 percent days abstinent
STANDARD_DEVIATION 24.92 • n=107 Participants
|
25.56 percent days abstinent
STANDARD_DEVIATION 23.12 • n=206 Participants
|
28 percent days abstinent
STANDARD_DEVIATION 23.19 • n=7 Participants
|
PRIMARY outcome
Timeframe: 6 daysThe percentage of days abstinent from alcohol is determined using the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the percent of days participants were abstinent during the practice quit period.
Outcome measures
| Measure |
Placebo
n=17 Participants
Matched to active medications
Placebo: Matched to active medication
|
Varenicline
n=17 Participants
1 mg twice a day
Varenicline: 1 mg twice a day
|
Naltrexone
n=14 Participants
50 mg once a day
Naltrexone: 50 mg once a day
|
|---|---|---|---|
|
Percentage of Days Abstinent
|
80.59 percent days
Standard Error 6.67
|
75.62 percent days
Standard Error 6.87
|
77.59 percent days
Standard Error 7.31
|
PRIMARY outcome
Timeframe: 6 daysThe drinks per drinking day outcome is determined using the the Timeline Follow Back (TLFB). The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14). Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database. The primary outcome variable was calculated as the number of drinks per drinking day during the practice quit period.
Outcome measures
| Measure |
Placebo
n=17 Participants
Matched to active medications
Placebo: Matched to active medication
|
Varenicline
n=17 Participants
1 mg twice a day
Varenicline: 1 mg twice a day
|
Naltrexone
n=14 Participants
50 mg once a day
Naltrexone: 50 mg once a day
|
|---|---|---|---|
|
# of Drinks Per Drinking Day
|
1.66 number of drinks per drinking day
Standard Error 0.63
|
2.19 number of drinks per drinking day
Standard Error 0.65
|
2.73 number of drinks per drinking day
Standard Error 0.69
|
PRIMARY outcome
Timeframe: Cue reactivity paradigm takes place on Day 1 and on Day 14. Craving is measured 3 min after each cue exposureRandomized participants completed a cue-exposure paradigm at two time points during the study, once on Day 1 prior to ingesting the first does of study medication, and again on Day 14. After every 3 minutes of exposure (water and alcohol), participants rated their urge to drink on the Alcohol Urge Questionnaire (AUQ). The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving, with higher total scores indicating higher craving and a minimum score of 8 and maximum score of 56. Alcohol urge questionnaire score (alcohol minus water) is the primary outcome for the cue-reactivity paradigm. The investigators are primarily interested in the difference in craving from post-treatment (day 14) to pre-treatment (randomization/day 1).
Outcome measures
| Measure |
Placebo
n=19 Participants
Matched to active medications
Placebo: Matched to active medication
|
Varenicline
n=19 Participants
1 mg twice a day
Varenicline: 1 mg twice a day
|
Naltrexone
n=15 Participants
50 mg once a day
Naltrexone: 50 mg once a day
|
|---|---|---|---|
|
Cue-induced Craving
|
-0.11 units on a scale
Standard Error 0.35
|
0.31 units on a scale
Standard Error 0.33
|
-0.32 units on a scale
Standard Error 0.37
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Varenicline
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Naltrexone
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=19 participants at risk
Matched to active medications
Placebo: Matched to active medication
|
Varenicline
n=19 participants at risk
1 mg twice a day
Varenicline: 1 mg twice a day
|
Naltrexone
n=15 participants at risk
50 mg once a day
Naltrexone: 50 mg once a day
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea or Vomiting
|
5.3%
1/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
26.3%
5/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
20.0%
3/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Psychiatric disorders
Irritability or Anger
|
26.3%
5/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
31.6%
6/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
66.7%
10/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Gastrointestinal disorders
Abdominal Pain or Cramps
|
15.8%
3/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
21.1%
4/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
26.7%
4/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Eye disorders
Yellow Eyes
|
10.5%
2/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
5.3%
1/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
6.7%
1/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Reproductive system and breast disorders
Increased Desire for Sex
|
31.6%
6/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
26.3%
5/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
33.3%
5/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Psychiatric disorders
Nervousness
|
26.3%
5/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
26.3%
5/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
46.7%
7/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Ear and labyrinth disorders
Ringing in the Ears
|
0.00%
0/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
10.5%
2/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
20.0%
3/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Decrease in Appetite
|
10.5%
2/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
21.1%
4/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
26.7%
4/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Psychiatric disorders
Depression
|
21.1%
4/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
21.1%
4/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
20.0%
3/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Fatigue
|
42.1%
8/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
42.1%
8/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
53.3%
8/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Difficulty in Staying Awake
|
21.1%
4/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
15.8%
3/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
26.7%
4/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Metabolism and nutrition disorders
Increase in Appetite
|
21.1%
4/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
21.1%
4/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
40.0%
6/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Eye disorders
Blurred Vision
|
5.3%
1/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
0.00%
0/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
13.3%
2/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Drowsiness
|
15.8%
3/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
52.6%
10/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
20.0%
3/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Headache
|
15.8%
3/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
31.6%
6/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
33.3%
5/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Night Sweats
|
10.5%
2/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
10.5%
2/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
26.7%
4/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Psychiatric disorders
Mental Confusion
|
10.5%
2/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
10.5%
2/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
13.3%
2/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Psychiatric disorders
Anxiety
|
26.3%
5/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
36.8%
7/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
60.0%
9/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Joint or Muscle Pain
|
5.3%
1/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
21.1%
4/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
53.3%
8/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Dizziness
|
5.3%
1/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
15.8%
3/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
20.0%
3/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Reproductive system and breast disorders
Sexual Problems
|
0.00%
0/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
5.3%
1/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
13.3%
2/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Difficulty Sleeping
|
31.6%
6/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
31.6%
6/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
53.3%
8/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
General disorders
Fever or Chills
|
0.00%
0/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
5.3%
1/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
6.7%
1/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
|
Reproductive system and breast disorders
Decreased Desire for Sex
|
5.3%
1/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
10.5%
2/19 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
26.7%
4/15 • Adverse event data was collected for each participant between randomization to Day 14 (final day of study).
Adverse event data was collected on a daily basis during the practice quit using the 24 items form the side effects checklist (SAFTEE) ) (Jacobson et al. 1986; Levine and Schooler 1986).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place