Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study

Who is this study for? Patients with Bipolar Disorder, Cannabis Use Disorder
What treatments are being studied? Gabapentin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
United States
South Carolina
Medical University Of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Sara Hix
hixs@musc.edu
843-792-7500
Time Frame
Start Date: 2022-02-24
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 68
Treatments
Experimental: Group A - Gabapentin
Placebo_comparator: Group B - Placebo
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov