RecruitingPhase 2NCT05064319

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

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


Sponsor

Medical University of South Carolina

Enrollment

68 participants

Start Date

Feb 24, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether gabapentin (a medication that calms overactive nerve signals) can help people who have both bipolar disorder and cannabis use disorder — two conditions that often occur together and are difficult to treat simultaneously. Researchers believe gabapentin may rebalance brain chemistry disrupted by both conditions. **You may be eligible if...** - You are aged 18–65 and have been diagnosed with both bipolar disorder (type I or II) and moderate-to-severe cannabis use disorder - You use cannabis as your primary substance of concern and had a positive urine test at screening - You are already taking a mood stabilizer (e.g., lithium, valproate, lamotrigine, or an antipsychotic) **You may NOT be eligible if...** - You have another primary psychiatric diagnosis (e.g., schizophrenia) - You have moderate-to-severe use of other substances (other than cannabis or tobacco) in the past 60 days - You have a neurological condition like epilepsy or a history of serious brain injury - You have had ECT (electroconvulsive therapy) in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGabapentin

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.

DRUGPlacebo

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.


Locations(1)

Medical University Of South Carolina

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05064319


Related Trials