NCT03327792

Mavoglurant in Alcohol Drinking

A Pilot Study on the Safety and Efficacy of Mavoglurant in Alcohol Drinking

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this alcohol-interaction pilot study is to provide information on the effect of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related responses. This is a between subjects double blind randomized design in which the investigators plan to run 40 subjects to obtain 28 completers.

Detailed description

The purpose of this alcohol-interaction pilot study is to provide information on the effect of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related responses. This is a between subjects double blind randomized design in which the investigators plan to run 40 subjects to obtain 28 completers. Subjects will participate in two lab sessions, one prior to taking medication and one following 7-10 days of mavoglurant/placebo. During each session, participants will receive successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to the peak BAC the investigators have observed in prior research studies. Subjects will be monitored throughout the lab session and will receive a phone call two days following the 2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any remaining side effects from the medication.

Conditions

• Alcohol Drinking

Interventions

Type	Name	Description
DRUG	Mavoglurant	200 mg Mavoglurant
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-02-07
• Primary completion: 2023-07-13
• Completion: 2023-07-13
• First posted: 2017-10-31
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study