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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedical University of South Carolina

About this trial

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

Qualifiers

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

Disqualifiers

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

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

Trial design

Treatments tested in this trial

  • Gabapentin
  • Placebo

Treatment groups

68 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator