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NCT04249882 · ClinicalTrials.gov registry record · Phase 2
A Novel Human Lab Model for Screening AUD Medications
A Phase 2 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT04249882: Completed Phase 2 study, sponsored by University of California, Los Angeles.
NCT04249882 is a Phase 2 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04249882, a Phase 2 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
This study design consists of a randomized, double-blind, placebo-controlled, 3-arm, parallel-group study of naltrexone (50 mg QD) and varenicline (1 mg BID). A total of 108 men and women with current AUD (moderate or severe) and reporting intrinsic motivation to change their drinking, will be randomly assigned to receive naltrexone (50 mg QD), varenicline (1 mg BID) or matched placebo. Post-randomization, all participants will complete an alcohol cue-reactivity paradigm prior to the initial dose of study medication. After a week-long medication titration period, participants will be asked to complete a 7-day practice quit attempt, during which they will have daily virtual visits (phone and online) where they will report on their alcohol use. Additionally, a second cue-reactivity paradigm will be conducted 90 minutes following study drug administration on final day of the practice quit attempt (Day 14).
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Varenicline
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2020-01-28 |
| Est. Completion | 2022-06-28 |
| Phase | Phase 2 |
What the finished NCT04249882 record still lists
NCT04249882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04249882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04249882 about?
NCT04249882 is a clinical study titled "A Novel Human Lab Model for Screening AUD Medications". This study design consists of a randomized, double-blind, placebo-controlled, 3-arm, parallel-group study of naltrexone (50 mg QD) and varenicline (1 mg BID). A total of 108 men and women with current AUD (moderate or severe) and reporting intrinsic motivation to change their drinking, will be rando...
What is the current status of trial NCT04249882?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2020-01-28. Estimated completion is 2022-06-28.
What interventions are being tested in trial NCT04249882?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT04249882?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04249882's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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