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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05064319
The ClinicalTrials.gov registry entry for NCT05064319 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (80% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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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.