NCT06136195

Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.

Detailed description

This project will use a double-blind, placebo-controlled, within-subject design to examine mavoglurant effects on alcohol craving, drinking, and subjective responses. Non-treatment seeking, heavy drinkers with Alcohol Use Disorder (AUD) will undergo 2 lab sessions, which include a Cue Exposure (craving) Paradigm (CEP) and an Alcohol Drinking Paradigm (ADP), as well as 1-week and 1-month follow up appointments. Prior to the first lab session, participants will be randomized to receive either 200 mg of mavoglurant or placebo. For the second lab session, participants will receive the other condition, mavoglurant or placebo, that they did not receive in the first lab session. Each session will be separated by at least a 5-8 day washout period to allow for complete washout of mavoglurant. This is followed by 1-week and 1-month follow up appointments.

Conditions

• Alcohol Consumption
• Heavy Drinker
• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
DRUG	Mavoglurant	The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2023-11-18
• Last updated: 2025-08-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study