NCT05064319 Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
| NCT ID | NCT05064319 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of South Carolina |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2022-02-24 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 68 participants in total. It began in 2022-02-24 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
James J Prisciandaro, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT05064319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05064319 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05064319 currently recruiting?
Yes, NCT05064319 is actively recruiting participants. Contact the research team at hixs@musc.edu for enrollment information.
Where is the NCT05064319 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05064319 clinical trial?
NCT05064319 is sponsored by Medical University of South Carolina. The principal investigator is James J Prisciandaro, PhD at Medical University of South Carolina. The trial plans to enroll 68 participants.
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