RECRUITING

Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers

Conditions

Alcohol Consumption Heavy Drinker Alcohol Use Disorder (AUD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers

Quick Facts

Study Start:2024-07-01

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06136195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Suchitra Krishnan, PhD

CONTACT

203-974-7595

suchitra.krishnan-sarin@yale.edu

Thomas Liss

CONTACT

(203)974-7555

thomas.liss@yale.edu

Study Locations (Sites)

Connecticut Mental Health Center (SAC and SATU)

New Haven, Connecticut, 06511

United States

Yale New Haven Hospital

New Haven, Connecticut, 06512

United States

Collaborators and Investigators

Sponsor: Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2024-07-01

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Consumption
Heavy Drinker
Alcohol Use Disorder (AUD)