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Could a pill help heavy drinkers cut back? new trial tests mavoglurant

NCT ID NCT06136195

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early-stage study tests whether mavoglurant, a drug taken as a pill, can reduce alcohol cravings and drinking in people who drink heavily. Researchers will give the drug or a placebo to 63 adults with Alcohol Use Disorder and measure how much they drink and crave alcohol. The goal is to see if mavoglurant might help control drinking behavior.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mavoglurant
What this could lead to
If it works, this could point toward a new medication to help heavy drinkers control cravings and reduce alcohol consumption.
What could go wrong
This is a very early Phase 1 trial with only 63 people, so results may not apply widely. The drug may not reduce drinking or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 63 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

alcohol abuse Alcohol Drinking Alcoholic Intoxication

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Connecticut Mental Health Center (SAC and SATU)

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06512, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.