Effects of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers

Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers

This study is testing if a new drug called mavoglurant can help heavy drinkers with Alcohol Use Disorder reduce their cravings and drinking.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (estimated)
• Ages: 21 Years to 50 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 2 sites (New Haven, Connecticut and 1 other locations)
• Trial ID: NCT06136195 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of mavoglurant, a drug, on alcohol craving and consumption among heavy drinkers diagnosed with Alcohol Use Disorder (AUD). Participants will undergo a double-blind, placebo-controlled design, where they will receive either mavoglurant or a placebo during two lab sessions separated by a washout period. The study includes Cue Exposure and Alcohol Drinking Paradigms to assess the drug's effects on craving and drinking behavior, with follow-up appointments scheduled one week and one month after the sessions.

Who should consider this trial

Good fit: Ideal candidates are non-treatment seeking heavy drinkers aged 21-50 who meet the criteria for moderate to severe Alcohol Use Disorder.

Not a fit: Patients who are currently seeking alcohol treatment or have undergone treatment in the past six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new pharmacological approach to reduce alcohol cravings and consumption in individuals with AUD.

How similar studies have performed: Other studies have explored pharmacological interventions for AUD, but the specific use of mavoglurant in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).
2. Ability to read English at 6th grade level or higher.
3. Meet DSM-V criteria for moderate or severe Alcohol Use Disorder (AUD).
4. Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the Alcohol Drinking Paradigm (ADP).

Exclusion Criteria:

1. Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.
2. Meet current Diagnostic and Statistical Manual v.5 (DSM-V) criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.
3. Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines and barbiturates.
4. Psychotic or other severe psychiatric disorders as determined by clinical evaluation (Structured Clinical Interview for DSM-V; SCID). Note that if a subject endorses any harm/risk behaviors (e.g. suicidal/homicidal risk) a licensed clinician will be consulted immediately.
5. Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.
6. Medical conditions that would contraindicate the consumption of alcohol or use of mavoglurant.
7. Clinically significant abnormalities in screening laboratories, including aspartate aminotransferase (AST) \>3 times upper limit of normal (ULN); alanine aminotransferase (ALT) \> 3 times ULN; total bilirubin \>1.5 times ULN; serum creatinine \>2.0 times ULN.
8. Neurological trauma or disease, delirium or hallucinations, or clinically significant or unstable medical conditions, including uncontrolled hypertension or diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases, which in the opinion of the study physician and Principal Investigator, may put the patient at risk because of participation in the study.
9. Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores of 8 or greater or a history of significant repeated alcohol withdrawals to reduce the likelihood of withdrawal symptomatology if subjects reduce their drinking.
10. Women who are pregnant or nursing.
11. Participants who refuse to use a reliable method of birth control.
12. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.
13. Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.
14. Individuals who report heavy drinking days in the 2 days prior to their intake appointment but have a negative ethyl glucuronide (EtG) test to rule out subjects who are misrepresenting their drinking history.
15. Subjects who have donated blood within the past 6 weeks.

Where this trial is running

New Haven, Connecticut and 1 other locations

• Connecticut Mental Health Center (SAC and SATU) — New Haven, Connecticut, United States (Recruiting)
• Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Principal investigator: Suchitra Krishnan, PhD — Yale University
• Study coordinator: Suchitra Krishnan, PhD

Conditions Alcohol Consumption; Heavy Drinker; Alcohol Use Disorder