Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers

Launched by YALE UNIVERSITY · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called mavoglurant to see how it may help reduce cravings for alcohol and lower drinking levels in people who drink heavily. The trial is currently looking for participants aged 21 to 50 who drink a significant amount of alcohol each week and have been diagnosed with moderate or severe Alcohol Use Disorder (AUD). To join, individuals must be able to read English at a 6th-grade level or higher and meet certain drinking criteria, such as consuming 30-70 drinks per week for men and 20-65 for women.

Participants in the trial can expect to be part of a research study where they will take the medication and have their drinking patterns monitored over time. It's important to note that this study is not for individuals currently seeking treatment for alcohol use or those with certain medical conditions or severe psychiatric issues. This trial provides a unique opportunity to potentially benefit from a new treatment while contributing to research that could help others struggling with alcohol use.

Gender

ALL

Eligibility criteria

• 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.