ClinicalTrials.gg
RecruitingNCT06136195Updated Aug 21, 2026

Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers

A Phase 1 interventional study of Mavoglurant in Alcohol Consumption, Heavy Drinker and Alcohol Use Disorder (AUD), sponsored by Yale University. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Primary conditionAlcohol Drinking(the registry's first term)UnverifiedIs this wrong?Alcohol Drinking is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Yale University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
All
01

Study summary

The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.

Read the detailed description

This project will use a double-blind, placebo-controlled, within-subject design to examine mavoglurant effects on alcohol craving, drinking, and subjective responses. Non-treatment seeking, heavy drinkers with Alcohol Use Disorder (AUD) will undergo 2 lab sessions, which include a Cue Exposure (craving) Paradigm (CEP) and an Alcohol Drinking Paradigm (ADP), as well as 1-week and 1-month follow up appointments. Prior to the first lab session, participants will be randomized to receive either 200 mg of mavoglurant or placebo. For the second lab session, participants will receive the other condition, mavoglurant or placebo, that they did not receive in the first lab session. Each session will be separated by at least a 5-8 day washout period to allow for complete washout of mavoglurant. This is followed by 1-week and 1-month follow up appointments.

02

Conditions studied

  • Alcohol Consumption
  • Heavy Drinker
  • Alcohol Use Disorder (AUD)

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03

In context

Alcohol Drinking Unverified

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's planned enrollment of 63 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 () 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. abnormalities in screening laboratories, including (AST) >3 times (ULN); alanine aminotransferase (ALT) > 3 times ULN; total >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 .
  12. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.
  13. Subjects who have taken any 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
63 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Mavoglurant

  • Experimental
    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.

    Drug: Mavoglurant

Interventions

  • The 200mg mavoglurant will be administered in the form of two 100mg oral tablets. Placebo will be administered with matching tablets.

    Also known as: STP7

06

What researchers measure

Primary outcomes

  1. Change in the number of drinks consumed

    The number of drinks consumed during the adlib session will be recorded

    Time frame: Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).

  2. 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.

    Time frame: Lab Session 1 (Day 1); Lab Session 2 (5-8 days after Lab Session 1).

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Deidentified individual data will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06136195
Lead sponsor
Yale University
Responsible party
Suchitra Krishnan-Sarin (Professor of Psychiatry, Yale University) — Principal investigator
First posted
Nov 18, 2023
Start date
Jul 1, 2024
Primary completion
May 31, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

Suchitra Krishnan, PhD
Contact
suchitra.krishnan-sarin@yale.edu
203-974-7595
Thomas Liss
Contact
thomas.liss@yale.edu
(203)974-7555
Suchitra Krishnan, PhD
principal investigator · Yale University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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