Trials / Recruiting
RecruitingNCT05064319
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- Sponsor
- Medical University of South Carolina · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.
Conditions
- Bipolar Disorder
- Cannabis Use
- Schizoaffective Disorder, Bipolar Type
- Bipolar I Disorder
- Bipolar II Disorder
- Cannabis Use Disorder, Mild
- Cannabis Use Disorder, Moderate
- Cannabis Use Disorder, Severe
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gabapentin | After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive gabapentin 2-3 times a day for a total of 17 days. |
| DRUG | Placebo | After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive placebo 2-3 times a day for a total of 17 days. |
Timeline
- Start date
- 2022-02-24
- Primary completion
- 2026-06-30
- Completion
- 2026-06-30
- First posted
- 2021-10-01
- Last updated
- 2025-07-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05064319. Inclusion in this directory is not an endorsement.