Novel mGluR5 Modulator Effects on Alcohol Drinking and MRI Outcomes

NCT04831684 | Completed Phase 1 FDA Drug

• 1 other identifier: Pro00102334
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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. There are 4 study visits including 2 MRI scans.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

• Number of drinks consumed during bar-lab paradigm (free drinking period)

  165 minutes

• Change in Gamma aminobutyric acid (GABA) and glutamate levels

  Acquired via spectroscopy sequence completed at baseline and day 7 scans

  baseline to day 7

• Levels of cortical activation to visual cues of alcohol

  Acquired via functional magnetic resonance imaging completed at baseline and day 7 scans

  baseline to day 7

Study Arms (2)

Group A

PLACEBO COMPARATOR

Drug: Placebo

Group B

EXPERIMENTAL

Drug: GET73

Interventions

GET73 DRUG

Participants will be getting GET73 for 8 days of dosing.

Group B

Placebo DRUG

Participants will be getting placebo for 8 days of dosing.

Group A

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Charleston Alcohol Research Center, Institute of Psychiatry, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• James Prisciandaro

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: September 15, 2021
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified participant data will be uploaded to the NIMH Data Archive twice yearly (by April 1 and October 1) during the course of this study, and will remain available with no end date.
• Access Criteria: Data and supporting documentation submitted to the NIMH Data Archive may be accessed and used broadly by approved users for research and other activities as authorized by and consistent with law.

Locations

US (1)