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Effect of GET73 on MRS Measures of Central Glutamate and GABA in Individuals With Alcohol Use Disorder

NCT03418623 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-10-08

No results posted yet for this study

Summary

This study is aimed at examining whether GET73 modulates the indices of central glutamate and γ-aminobutyric acid (GABA) levels in recently abstinent subjects that meet Alcohol Use Disorder (AUD) criteria, as measured by proton nuclear magnetic resonance spectroscopy (¹H-MRS), in order to provide a human translation of the findings demonstrated in different preclinical models, both in vitro and in vivo. In addition, the study will examine the effects of GET73 on alcohol cue induced brain activation by using a well-established blood-oxygen-level-dependent (BOLD) functional magnetic resonance (fMRI) paradigm in the same individuals. In summary, the study should provide important information on (i) the potential mechanism of action of GET73, (ii) on the brain mechanisms that would support its potential use for reduction in craving and drinking in AUD patients, and (iii) expand data on its safe use as a medication in heavy drinking individuals.

Conditions

Interventions

DRUG

GET73

GET73 300 mg oral capsules, administered three times a day on Visit 2 and 4, and twice a day on Visit 3 and 5.

OTHER

Placebo

Placebo oral capsules, administered three times a day on Visit 2 and 4, and twice a day on Visit 3 and 5.

Sponsors & Collaborators

  • Latis S.r.l.

    collaborator INDUSTRY

  • Laboratorio Farmaceutico Ct S.r.l.

    lead INDUSTRY

Principal Investigators

  • Raymond F Anton, MD · Department of Psychiatry and Behavioral Sciences - Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-08
Primary Completion
2020-03-13
Completion
2020-03-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03418623 on ClinicalTrials.gov