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NCT03220776 · ClinicalTrials.gov registry record · Phase 2

Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics

A Phase 2 study of Alcohol Use Disorder and Bipolar Disorder, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target
1
Study location

NCT03220776 is a Phase 2 study of Alcohol Use Disorder and Bipolar Disorder that has completed, run by Medical University of South Carolina. The registered enrollment target is 54 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03220776, a Phase 2 study of Alcohol Use Disorder and Bipolar Disorder, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Alcohol Use Disorder Bipolar Disorder

Interventions

  • DRUG Gabapentin
  • DRUG N-Acetylcysteine
  • DRUG Placebo Oral Tablet

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2017-08-07
Est. Completion 2022-11-21
Phase Phase 2

Sponsor

Medical University of South Carolina

755 total trials

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What the Registry Record Tells You About NCT03220776

The ClinicalTrials.gov registry entry for NCT03220776 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (84% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Gabapentin is the first listed.

NCT03220776 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.

Frequently Asked Questions

What is clinical trial NCT03220776 about?

NCT03220776 is a clinical study titled "Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics". 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.,...

What is the current status of trial NCT03220776?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2017-08-07. Estimated completion is 2022-11-21.

What conditions does trial NCT03220776 study?

This clinical trial studies the following conditions: Alcohol Use Disorder, Bipolar Disorder.

What interventions are being tested in trial NCT03220776?

The interventions under investigation include: Gabapentin (DRUG), N-Acetylcysteine (DRUG), Placebo Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT03220776?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03220776 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.