Status:
RECRUITING
Novel MGluR5 Modulator Effects on Alcohol Drinking and MRI Outcomes
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-40 years
Phase:
PHASE1
PHASE2
Brief Summary
This study evaluates the effects of the medication GET73 among non-treatment-seeking individuals who regularly drink alcohol. Participants in the study will take GET73 or placebo for an 8-day study. T...
Eligibility Criteria
Inclusion
- Age 21-40 (to focus on an age group still on a trajectory of increasing alcohol consumption, consistent with our pilot data and past iterations of the ARC).
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current Alcohol Use Disorder, with at least Moderate severity.
- Reports drinking, on average, at least 20 standard alcoholic drinks per week for at least the past 3 months.
- Currently not engaged in, and does not want treatment for, alcohol-related problems.
- Able to read and understand questionnaires and informed consent.
- Lives within 50 miles of the study site.
- Able to maintain abstinence from alcohol the evening prior to appointments (without the aid of detoxification medications), as determined by self-report and breathalyzer measurements.
- Amenable to drinking liquor in fruit juice.
Exclusion
- Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
- Any psychoactive substance use (except marijuana and nicotine) within the last 30 days, as indicated by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels.
- Current DSM-5 Axis I diagnosis, including major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.
- Current suicidal ideation or homicidal ideation.
- Using CYP2C19 and/or CYP3A4 inhibitors or inducers in the 14 days before dosing or during the study.
- Need for maintenance or acute treatment with any psychoactive medication, including antiepileptic medications.
- Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate).
- History of severe alcohol withdrawal (e.g., tremor, sweating, anxiety, seizure, delirium tremens), as evidenced by self-report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).
- Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
- Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.
- Has hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2.5 times normal at screening.
- Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
- Current charges pending for a violent crime (not including DUI-related offenses).
- Lack of a stable living situation.
- Presence of ferrous metal in the body, as evidenced by metal screening and self-report.
- Severe claustrophobia or extreme obesity that preclude placement in the MRI scanner.
- Neurological disease or history of head injury with \> 2 minutes of unconsciousness.
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04831684
Start Date
September 15 2021
End Date
April 22 2026
Last Update
January 28 2025
Active Locations (1)
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1
Charleston Alcohol Research Center, Institute of Psychiatry, Medical University of South Carolina
Charleston, South Carolina, United States, 29425