Actively Recruiting
Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
Led by Yale University · Updated on 2026-06-08
63
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the drug mavoglurant affects alcohol craving and drinking in heavy drinkers with Alcohol Use Disorder (AUD). This study uses a double-blind, placebo-controlled design to compare the effects of mavoglurant and placebo on alcohol consumption and cravings. The goal is to understand how mavoglurant influences drinking behavior and subjective responses in non-treatment seeking individuals with moderate or severe AUD. Participants will take part in two lab sessions, each preceded by a single dose of either 200 mg mavoglurant or a matching placebo. The sessions include a Cue Exposure Paradigm to measure craving and an Alcohol Drinking Paradigm to observe drinking behavior. The order of drug and placebo is randomized, with a 5 to 8 day washout period between sessions to clear the drug from the body. After the lab sessions, participants will have follow-up appointments at one week and one month. During the study, participants will be assessed on changes in the number of drinks consumed and their craving for alcohol during each lab session. The study includes questionnaires and structured clinical interviews to evaluate psychiatric status and drinking behavior. Safety labs and urine drug screens are monitored. The total participation involves two lab visits plus two follow-up visits over approximately one month, with careful monitoring throughout the study.
CONDITIONS
Brief Title
Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 21 to 50 years
- Ability to read English at a 6th grade level or higher
- Meet DSM-V criteria for moderate or severe Alcohol Use Disorder (AUD)
- Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women
You will not qualify if you...
- Currently seeking alcohol treatment or received treatment in the past 6 months
- Meet DSM-V criteria for substance use disorder except tobacco or mild cannabis use disorder
- Positive urine drug screens for opiates, cocaine, benzodiazepines, or barbiturates more than once at baseline
- Severe psychiatric disorders or psychosis
- Regular use of psychoactive drugs except stable antidepressant dose for 2 months
- Medical conditions contraindicating alcohol or mavoglurant use
- Abnormal liver or kidney function tests above specified limits
- Neurological trauma, delirium, hallucinations, or unstable medical conditions
- High risk of alcohol withdrawal symptoms (CIWA-Ar score 8 or higher)
- Pregnant or nursing women
- Refusal to use reliable birth control
- Dislike of spirits, as hard liquor is provided during the study
- Use of investigational drugs within 4 weeks prior to study
- Reported heavy drinking in 2 days before intake but negative EtG test
- Blood donation within 6 weeks prior to study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive a single dose of mavoglurant or placebo before each of two lab sessions, separated by a 5 to 8 day washout period, to examine effects on alcohol craving and drinking.
2 lab sessions separated by 5 to 8 days
Duration - 1 month
Participants complete follow-up appointments to assess longer-term effects one week and one month after the lab sessions.
2 visits (1-week and 1-month post lab sessions)
Trial Site Locations
Total: 2 locations
1
Connecticut Mental Health Center (SAC and SATU)
New Haven, Connecticut, United States, 06511
Actively Recruiting
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06512
Actively Recruiting
Research Team
S
Suchitra Krishnan, PhD
T
Thomas Liss
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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