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

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

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=93 Participants
41.84 years
STANDARD_DEVIATION 13.04 • n=4 Participants
42.40 years
STANDARD_DEVIATION 11.19 • n=27 Participants
41.87 years
STANDARD_DEVIATION 11.91 • n=483 Participants
Sex: Female, Male
Female
9 Participants
n=93 Participants
10 Participants
n=4 Participants
7 Participants
n=27 Participants
26 Participants
n=483 Participants
Sex: Female, Male
Male
10 Participants
n=93 Participants
9 Participants
n=4 Participants
8 Participants
n=27 Participants
27 Participants
n=483 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
Race (NIH/OMB)
Asian
3 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
3 Participants
n=483 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
1 Participants
n=483 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=93 Participants
5 Participants
n=4 Participants
4 Participants
n=27 Participants
14 Participants
n=483 Participants
Race (NIH/OMB)
White
7 Participants
n=93 Participants
9 Participants
n=4 Participants
7 Participants
n=27 Participants
23 Participants
n=483 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=93 Participants
3 Participants
n=4 Participants
2 Participants
n=27 Participants
9 Participants
n=483 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
2 Participants
n=483 Participants
Region of Enrollment
United States
19 participants
n=93 Participants
19 participants
n=4 Participants
15 participants
n=27 Participants
53 participants
n=483 Participants
Last 30 Days Drinks Per Drinking Day
5.46 number of drinks per drinking day
STANDARD_DEVIATION 2.39 • n=93 Participants
5.84 number of drinks per drinking day
STANDARD_DEVIATION 3.68 • n=4 Participants
5.89 number of drinks per drinking day
STANDARD_DEVIATION 3.48 • n=27 Participants
5.73 number of drinks per drinking day
STANDARD_DEVIATION 3.18 • n=483 Participants
Past Month Percent Day Abstinent
25.79 percent days abstinent
STANDARD_DEVIATION 21.16 • n=93 Participants
28.78 percent days abstinent
STANDARD_DEVIATION 24.92 • n=4 Participants
25.56 percent days abstinent
STANDARD_DEVIATION 23.12 • n=27 Participants
28 percent days abstinent
STANDARD_DEVIATION 23.19 • n=483 Participants

PRIMARY outcome

Timeframe: 6 days

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.

Outcome measures

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 days

The 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

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 exposure

Randomized 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

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

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
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).
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).
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

Dr. Lara Ray

University of California Los Angeles

Phone: 310-206-6756

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place