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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 is a Phase 2 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 53 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04249882
The ClinicalTrials.gov registry entry for NCT04249882 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04249882 reports 0 study locations.
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.
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