Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
2 other identifiers
interventional
63
1 country
2
Brief Summary
The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
August 3, 2025
August 1, 2024
1.9 years
November 9, 2023
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in the number of drinks consumed
The number of drinks consumed during the adlib session will be recorded
Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).
Change in craving for alcohol
The Cue Exposure Paradigm (CEP) is used to measure craving for alcohol. The task uses a questionnaire that is in the form of a Visual Analog Scale (VAS). The endpoints will be marked with a 0 on the left indicating no craving and a 20 on the right indicating severe craving. Participants will indicate how strong they are craving to drink alcohol. The VAS takes 2-3 minutes to complete.
Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).
Study Arms (2)
Mavoglurant 1st / Placebo 2nd
EXPERIMENTALParticipants randomized to the Mavoglurant 1st Arm will take a single dose of 200mg mavoglurant in the morning, prior to their 1st lab session. Then after a 5-8 day washout period, participants will have their 2nd lab session where they will take a matching placebo in the morning prior to the 2nd lab session.
Placebo 1st / Mavoglurant 2nd
EXPERIMENTALParticipants randomized to the Placebo 1st Arm will take a matching placebo in the morning, prior to their 1st lab session. Then after a 5-8 day washout period, participants will have their 2nd lab session where they will take a single dose of 200mg mavoglurant in the morning, prior to their 2nd lab session.
Interventions
The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.
Eligibility Criteria
You may qualify if:
- 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).
- Ability to read English at 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. 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).
You may not qualify if:
- Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.
- 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.
- Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines and barbiturates.
- 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.
- Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.
- Medical conditions that would contraindicate the consumption of alcohol or use of mavoglurant.
- 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.
- 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.
- 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.
- Women who are pregnant or nursing.
- Participants who refuse to use a reliable method of birth control.
- Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.
- Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.
- 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.
- Subjects who have donated blood within the past 6 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Connecticut Mental Health Center (SAC and SATU)
New Haven, Connecticut, 06511, United States
Yale New Haven Hospital
New Haven, Connecticut, 06512, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suchitra Krishnan, PhD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
November 9, 2023
First Posted
November 18, 2023
Study Start
July 1, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
August 3, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
Deidentified individual data will be shared.