NCT06489782

Developing a Novel Human Laboratory Paradigm for AUD Medication Screening

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The intent of the study is to develop two versions of the 'ability to resist' drinking model designed to screen Alcohol Use Disorder (AUD) medications.

Detailed description

Proposed is the development of two versions of the 'ability to resist' drinking model designed to screen AUD medications. Model 1 will examine the impact of alcohol cues and alcohol availability on the 'ability to resist' drinking and subsequent ad-lib drinking. Model 2 (alcohol cues \& alcohol availability + low dose prime) on the 'ability to resist' drinking and subsequent ad-lib drinking. This study will consist of an intake session, a physical exam, and two laboratory sessions. Each laboratory session will start with the presentation of the primes for Model 1 or 2, following which, participants will have the option of initiating an alcohol self-administration session or delaying initiation by five-minute increments for up to 50 minutes in exchange for monetary reinforcement. Subsequently, the alcohol self-administration session entails a 2-hour period in which participants can choose to drink their preferred beverage or receive monetary compensation for alcohol not consumed. The primary outcome measures for Aim 1 is the latency to start drinking (i.e., ability to resist drinking) and amount consumed during the self-administration sessions.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
OTHER	Model 1	Model 1 examines the impact of alcohol cues and alcohol availability on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period.
OTHER	Model 2	Model 2 examines the impact of alcohol cues and alcohol availability and a priming dose of alcohol (.04 g/dL) on latency to start drinking and amount consumed of a 0.12 g/dL dose of alcohol during a 2-hour ad-libitum period.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-03-15
• Completion: 2026-06-30
• First posted: 2024-07-08
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States