Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Diso… (NCT05064319) | Clinical Trial Compass
RecruitingPhase 2
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
United States68 participantsStarted 2022-02-24
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ages 18-65 years
✓. 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
✓. Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type
✓. Able to provide informed consent and read, understand, and accurately complete assessment instruments
✓. Willing to commit to medication treatment and follow-up assessments
✓. Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)
Exclusion criteria
✕. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
✕. Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days
What they're measuring
1
Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy
Timeframe: Baseline to end of treatment, approximately 17 days
. Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
✕. Any history of brain injury with loss of consciousness greater than 5 minutes
✕. Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
✕. Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
✕. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
✕. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range