Effects of a new medication on alcohol consumption and brain imaging

Effects of a Novel MGluR5 Negative Allosteric Modulator on Alcohol Drinking, Neurochemistry, and Brain Reactivity to Alcohol Cues in Alcohol Use Disorder

This study is testing a new medication called GET73 to see if it can help young adults who drink heavily reduce their alcohol consumption and how it affects their brain.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 21 Years to 40 Years
• Sex: All
• Sponsor: Medical University of South Carolina (Academic / other)
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT04831684 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of the medication GET73 on alcohol consumption among non-treatment-seeking individuals who regularly drink alcohol. Participants will be randomly assigned to receive either GET73 or a placebo over an 8-day period, with a total of four study visits that include two MRI scans to assess brain outcomes. The focus is on individuals aged 21-40 who meet the criteria for moderate Alcohol Use Disorder and consume a significant amount of alcohol weekly. The study aims to gather data on the medication's impact on drinking behavior and brain function.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 21-40 who meet the criteria for moderate Alcohol Use Disorder and consume at least 20 standard drinks per week.

Not a fit: Patients with current diagnoses of other substance use disorders, except for Nicotine Use Disorder, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for individuals struggling with Alcohol Use Disorder.

How similar studies have performed: Other studies have explored similar pharmacological approaches to treating Alcohol Use Disorder, showing promise in modulating drinking behavior.

Eligibility criteria

Inclusion Criteria:

1. 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).
2. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current Alcohol Use Disorder, with at least Moderate severity.
3. Reports drinking, on average, at least 20 standard alcoholic drinks per week for at least the past 3 months.
4. Currently not engaged in, and does not want treatment for, alcohol-related problems.
5. Able to read and understand questionnaires and informed consent.
6. Lives within 50 miles of the study site.
7. 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.
8. Amenable to drinking liquor in fruit juice.

Exclusion Criteria:

1. Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
2. 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.
3. 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.
4. Current suicidal ideation or homicidal ideation.
5. Using CYP2C19 and/or CYP3A4 inhibitors or inducers in the 14 days before dosing or during the study.
6. Need for maintenance or acute treatment with any psychoactive medication, including antiepileptic medications.
7. Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate).
8. 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).
9. Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
10. Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.
11. Has hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2.5 times normal at screening.
12. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
13. Current charges pending for a violent crime (not including DUI-related offenses).
14. Lack of a stable living situation.
15. Presence of ferrous metal in the body, as evidenced by metal screening and self-report.
16. Severe claustrophobia or extreme obesity that preclude placement in the MRI scanner.
17. Neurological disease or history of head injury with \> 2 minutes of unconsciousness.

Where this trial is running

Charleston, South Carolina

• Charleston Alcohol Research Center, Institute of Psychiatry, Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: James Prisciandaro — Medical University of South Carolina
• Study coordinator: Sara Hix

Conditions Alcohol Use Disorder