Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Medical University of South Carolina
You may qualify if…
- ✓ 1. Ages 18-65 years
- ✓ 2. Meet DSM-5 criteria for moderate or severe cannabis use disorder (CUD; within the past 3 months), provide a positive urine cannabinoid screen at baseline, and identify cannabis as the primary substance of abuse
- ✓ 3. Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type
- ✓ 4. Able to provide informed consent and read, understand, and accurately complete assessment instruments
- ✓ 5. Willing to commit to medication treatment and follow-up assessments
- ✓ 6. Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)
You may not qualify if…
- ✕ 1. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
- ✕ 2. Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days
- ✕ 3. Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
- ✕ 4. Any history of brain injury with loss of consciousness greater than 5 minutes
- ✕ 5. Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
- ✕ 6. Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
- ✕ 7. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
- ✕ 8. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
Where it's recruiting
Charleston
Source: ClinicalTrials.gov · NCT05064319 · last updated 2026-07-17