Using Gabapentin to Help People with Bipolar Disorder and Cannabis Use Issues
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study
This study is testing if Gabapentin can help adults with Bipolar Disorder and cannabis use issues feel better by balancing certain chemicals in their brain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05064319 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effects of Gabapentin, an FDA-approved medication, on individuals aged 18-65 who have both Bipolar Disorder and moderate to severe cannabis use disorder. Participants will be randomly assigned to receive either Gabapentin or a placebo for 17 days, with five study visits that include MRI brain scans and assessments of side effects. The study aims to understand how Gabapentin can help restore the balance of GABA and glutamate in the brain for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of Bipolar Disorder and moderate to severe cannabis use disorder.
Not a fit: Patients with primary psychiatric diagnoses other than Bipolar Disorder or those with uncontrolled neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve mood stability and reduce cannabis use in patients with co-occurring disorders.
How similar studies have performed: While this approach is novel in targeting the specific combination of Bipolar Disorder and cannabis use, similar studies have shown promise in using Gabapentin for other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages 18-65 years 2. 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 3. Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type 4. Able to provide informed consent and read, understand, and accurately complete assessment instruments 5. Willing to commit to medication treatment and follow-up assessments 6. Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic) Exclusion Criteria: 1. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia) 2. Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days 3. Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study 4. Any history of brain injury with loss of consciousness greater than 5 minutes 5. Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months) 6. Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant 7. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range 8. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range 9. Concomitant use of medications that could interfere with glutamatergic/GABAergic transmission (e.g., benzodiazepines, ceftriaxone, riluzole, memantine, ketamine, topiramate, vigabatrin), due to potential confounding effects 10. Concomitant use of opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin 11. Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded 12. Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception 13. Current suicidal or homicidal risk 14. Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale 15. Has taken gabapentin in the last month or experienced adverse effects/allergic reaction (e.g., angioedema) from it at any time 16. Significant claustrophobia and/or past negative experiences with MRI 17. Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)
Where this trial is running
Charleston, South Carolina
- Medical University Of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: James J Prisciandaro, PhD — Medical University of South Carolina
- Study coordinator: Sara Hix
- Email: hixs@musc.edu
- Phone: 843-792-7500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.