Phase 2
N=54
Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics
Alcohol Use Disorder · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03220776 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Prefrontal GABA+ Concentrations — 3.90; 3.93; 3.73 mmol/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-Acetylcysteine (Drug); Gabapentin (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prefrontal GABA+ Concentrations |
3.90; 3.93; 3.73 | — |
| PRIMARY Prefrontal Glx Concentrations |
21.59; 21.69; 22.25 | — |
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.
Eligibility Criteria
Inclusion:
- Meets DSM-V diagnostic criteria for Bipolar Disorder
- Using at least one mood stabilizing medication
- Meets diagnostic criteria Alcohol Use Disorder, with active drinking in the past month.
Exclusion:
- Serious medical or non-inclusionary psychiatric disease
- Concomitant use of benzodiazepine medications or any medications hazardous if taken with gabapentin/N-acetylcysteine
- History of clinically significant brain injury
- Presence of non-MRI safe material, or clinically significant claustrophobia.
Data sourced from ClinicalTrials.gov (NCT03220776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.