Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
NCT ID: NCT06136195
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
63 participants
INTERVENTIONAL
2024-07-01
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Mavoglurant 1st / Placebo 2nd
Participants 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.
Mavoglurant
The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.
Placebo 1st / Mavoglurant 2nd
Participants 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.
Mavoglurant
The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.
Interventions
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Mavoglurant
The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
50 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Yale University
OTHER
Responsible Party
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Suchitra Krishnan-Sarin
Professor of Psychiatry
Principal Investigators
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Suchitra Krishnan, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Connecticut Mental Health Center (SAC and SATU)
New Haven, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2000029675
Identifier Type: -
Identifier Source: org_study_id
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