Actively Recruiting
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
Led by Medical University of South Carolina · Updated on 2025-07-08
68
Participants Needed
1
Research Sites
226 weeks
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
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.
CONDITIONS
Official 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 18-65 years
- Meet DSM-5 criteria for moderate or severe cannabis use disorder within the past 3 months
- Positive urine cannabinoid test at baseline
- Cannabis is identified as the 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 complete assessments accurately
- Willing to commit to medication treatment and follow-up visits
- Prescribed daily use of at least one mood stabilizing medication (e.g., lithium, divalproex sodium, lamotrigine, carbamazepine, or 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 such as 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 safety or conduct
- Liver disease with elevated transaminase levels more than 3 times normal
- Renal insufficiency with creatinine levels more than 2 times normal
- Use of medications interfering with glutamatergic/GABAergic transmission (e.g., benzodiazepines, ceftriaxone, riluzole, memantine, ketamine, topiramate, vigabatrin)
- Use of opioids, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or other hazardous medications with gabapentin
- Use of azelastine, orphenadrine, oxomemazine, paraldehyde, or thalidomide
- Women who are pregnant, lactating, or not using adequate contraception
- Current suicidal or homicidal risk
- Montgomery-Asberg Depression Rating Scale score over 35 or Young Mania Rating Scale score over 25
- Use of gabapentin in the last month or history of adverse reactions to gabapentin
- Significant claustrophobia or past negative MRI experiences
- Presence of non-MRI safe implants or devices such as pacemakers or ferrous metal implants
AI-Screening
AI-Powered Screening
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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
CONTACT
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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