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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05064319
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Gabapentin — DRUG
    After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive gabapentin 2-3 times a day for a total of 17 days.
  • Placebo — DRUG
    After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive placebo 2-3 times a day for a total of 17 days.

Study Details

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.

Key Dates

Start date
Feb 24, 2022
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A - Gabapentin
  • Placebo Comparator: Group B - Placebo

Primary Outcome Measure

Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy [ Time Frame: Baseline to end of treatment, approximately 17 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University Of South CarolinaCharlestonSouth Carolina29425
Sara Hix
[email protected]
843-792-0572
James J Prisciandaro, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charleston, SC

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Medical University Of South Carolina· Charleston, SC

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