A Novel Human Lab Model for Screening AUD Medications
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).
Timeline
- Start
- 2020-01-28
- Primary completion
- 2022-06-28
- Completion
- 2022-06-28
Publications
- Baskerville WA, Grodin EN, Meredith LR, Ray LA. Interplay between alcohol cues and mood states during early abstinence: A daily diary study. Exp Clin Psychopharmacol. 2025 Jun;33(3):260-268. doi: 10.1037/pha0000770. Epub 2025 Mar 13.
- Ho D, Towns B, Grodin EN, Ray LA. A novel human laboratory model for screening medications for alcohol use disorder. Trials. 2020 Nov 23;21(1):947. doi: 10.1186/s13063-020-04842-w.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naltrexone | Small molecule | 50 mg | — |
| Comparator | Varenicline | Small molecule | 1 mg | — |