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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: Completed Phase 2 study of Alcohol Use Disorder and Bipolar Disorder, sponsored by Medical University of South Carolina.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Concentrations of GABA+, referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy (i.e., MEGA-PRESS).
Conditions Studied
Interventions
- DRUG Gabapentin
- DRUG N-Acetylcysteine
- DRUG Placebo Oral Tablet
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2017-08-07 |
| Est. Completion | 2022-11-21 |
| Phase | Phase 2 |
What the finished NCT03220776 record still lists
NCT03220776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03220776's enrollment target sits among peer trials
54 122nd of 184 higher than 63 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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