NCT06136195 Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers
| NCT ID | NCT06136195 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Alcohol Consumption |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 63 participants in total. It began in 2024-07-01 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.
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.
Contact & Investigator
Suchitra Krishnan, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06136195 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 50 Years, studying Alcohol Consumption. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06136195 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06136195 currently recruiting?
Yes, NCT06136195 is actively recruiting participants. Contact the research team at suchitra.krishnan-sarin@yale.edu for enrollment information.
Where is the NCT06136195 trial being conducted?
This trial is being conducted at New Haven, United States, New Haven, United States.
Who is sponsoring the NCT06136195 clinical trial?
NCT06136195 is sponsored by Yale University. The principal investigator is Suchitra Krishnan, PhD at Yale University. The trial plans to enroll 63 participants.