CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
N-Acetylcysteine +2 moredrug
Likely dose
N-Acetylcysteine 2,400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03220776
NCT03220776Phase 2Completed
CompareCT.gov

Imaging Framework for Testing GABAergic/Glutamatergic Drugs in Bipolar Alcoholics

Medical University of South Carolina·interventional·Posted Jul 18, 2017·Updated Dec 13, 2023

In Brief

A Phase 2 clinical trial evaluating N-Acetylcysteine, Gabapentin, and 1 other intervention for Alcohol Use Disorder and Bipolar Disorder. Completed, enrolled 54 participants across 1 site.

Detailed Summary

The proposed 3-week, double-blind, crossover, proof of concept study aims to manipulate neurochemical dysfunctions characteristic of individuals with co-occurring BD and AUD (i.e., abnormally low prefrontal GABA and glutamate), using medications that have been shown to normalize cortical GABA (i.e., gabapentin) and glutamate (i.e., NAC) levels in past research, and to evaluate medication-related changes in response inhibition and alcohol cue-reactivity fMRI tasks as well as drinking and mood in individuals with AUD+BD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder, Bipolar Disorder
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 18, 2017
Enrollment StartAug 7, 2017
Primary CompletionNov 21, 2022
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.0 years ago

Interventions

N-Acetylcysteinedrug

5 day trial of N-acetylcysteine with titration to 2,400mg

Gabapentindrug

5 day trial of gabapentin with titration to 1,200mg

Placebo Oral Tabletdrug

5 day trial of matched placebo