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Recruiting Phase 2 NCT05064319

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders

Trial Parameters

Condition Bipolar Disorder
Sponsor Medical University of South Carolina
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 68
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2022-02-24
Completion 2026-06-30
Interventions
GabapentinPlacebo

Brief 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.

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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 o

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