CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 34 enrolled
Drug / intervention
Mavoglurant +1 moredrug
Likely dose
Mavoglurant 200 mgAI-extracted
Key inclusion· 4
  • Ages 21 to 50 years old
  • Social drinkers
  • Able to read English at 6th grade level or higher and complete study evaluations
  • Willing to abstain from drinking alcohol during the outpatient study medication treatment period
Key exclusion· 12
  • Currently seeking treatment for alcohol drinking
  • Current DSM-V criteria for substance use disorder other than alcohol or nicotine
  • Positive urine drug screen after intake for opiates, cocaine, marijuana, benzodiazepines, or barbiturates
  • Regular use of psychoactive drugs including anxiolytics and antidepressants

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03327792
NCT03327792Phase 1Completed

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

Yale University·interventional·Posted Oct 31, 2017·Updated Aug 6, 2024

In Brief

A Phase 1 clinical trial evaluating Mavoglurant and Placebo for Alcohol Drinking. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 31, 2017
Enrollment StartFeb 7, 2018
Primary CompletionJul 13, 2023
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 8.7 years ago

Interventions

Mavoglurantdrug

200 mg Mavoglurant

Placebodrug

Placebo