Actively Recruiting
Gabapentin for Restoring GABA/Glutamate Balance in Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled MRI Study
Led by Medical University of South Carolina · Updated on 2025-07-08
68
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of an FDA-approved medication called Gabapentin in adults aged 18 to 65 who have Bipolar Disorder and also smoke marijuana. The study focuses on individuals with moderate to severe cannabis use disorder and co-occurring bipolar or schizoaffective disorders. The goal is to understand how Gabapentin affects brain chemicals related to GABA and glutamate balance, which are important for brain function. Participants will be randomly assigned to receive either Gabapentin or a matching placebo for 17 days. They will take the study medication two to three times daily during this period. The study includes five visits where participants will undergo brain MRI scans twice—once before starting medication and once after treatment ends—along with completing questionnaires and clinical interviews to assess their condition and any side effects. Throughout the study, participants will be closely monitored with consistent assessments of side effects and clinical measures. The main outcome measured is the change in GABA levels in the brain's prefrontal area from the start to the end of treatment. This comprehensive evaluation helps researchers understand how Gabapentin might influence brain chemistry in people with these co-occurring disorders during the 17-day treatment.
CONDITIONS
Brief Title
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 65 years
- Meet DSM-5 criteria for moderate or severe cannabis use disorder within the past 3 months
- Positive urine cannabinoid screen at baseline
- Identify cannabis as primary substance of abuse
- Meet DSM-5 criteria for bipolar I or II disorder or schizoaffective disorder, bipolar type
- Able to provide informed consent and understand assessment tools
- Willing to commit to medication treatment and follow-up assessments
- Prescribed daily use of at least one mood stabilizing medication (e.g., lithium, divalproex sodium, lamotrigine, carbamazepine, second generation antipsychotic)
You will not qualify if you...
- Primary psychiatric diagnosis other than bipolar disorder (e.g., schizophrenia)
- Moderate or severe substance use disorder other than cannabis or tobacco within past 60 days
- Uncontrolled neurological conditions (e.g., epilepsy)
- History of brain injury with loss of consciousness over 5 minutes
- History of mental retardation, dementia, or recent electroconvulsive therapy within past 3 months
- Uncontrolled medical conditions affecting study conduct or safety
- Liver disease with transaminase levels over 3 times normal
- Renal insufficiency with creatinine over 2 times normal
- Use of medications interfering with glutamatergic/GABAergic transmission
- Use of opioid medications, benzodiazepines, barbiturates, or other hazardous medications with gabapentin
- Use of contraindicated medications like azelastine, orphenadrine, oxomemazine, paraldehyde, thalidomide
- Women who are pregnant, lactating, or refuse adequate contraception
- Current suicidal or homicidal risk
- Montgomery-Asberg Depression Rating Scale score over 35 or Young Mania Rating Scale score over 25 at baseline
- Gabapentin use in last month or history of adverse reaction to gabapentin
- Significant claustrophobia or negative MRI experience
- Presence of non-MRI safe materials such as ferrous implants or pacemaker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 17 days
Participants take gabapentin or placebo 2 to 3 times a day while undergoing assessments and MRI scans before and after treatment.
1 baseline visit and 1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
S
Sara Hix
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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