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NCT05064319 · ClinicalTrials.gov registry record · Phase 2
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
A Phase 2 study of Bipolar Disorder and Cannabis Use, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT05064319: Recruiting Phase 2 study of Bipolar Disorder and Cannabis Use, sponsored by Medical University of South Carolina.
NCT05064319 is a Phase 2 study of Bipolar Disorder and Cannabis Use that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 68 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064319, a Phase 2 study of Bipolar Disorder and Cannabis Use, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gabapentin
Study Locations (1)
South Carolina
- Medical University Of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2022-02-24 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What NCT05064319 shows while recruiting
NCT05064319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (80% lower).
The record links to 8 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05064319 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT05064319 about?
NCT05064319 is a clinical study titled "Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders". 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 stu...
What is the current status of trial NCT05064319?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2022-02-24. Estimated completion is 2026-06-30.
What conditions does trial NCT05064319 study?
This clinical trial studies the following conditions: Bipolar Disorder, Cannabis Use, Bipolar I Disorder, Bipolar II Disorder, Schizoaffective Disorder, Bipolar Type.
What interventions are being tested in trial NCT05064319?
The interventions under investigation include: Placebo (DRUG), Gabapentin (DRUG).
Who is sponsoring clinical trial NCT05064319?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05064319 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 Bipolar 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 NCT05064319's enrollment target sits among peer trials
68 84th of 162 higher than 79 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar 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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