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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Sep 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Gabapentin in people who have Bipolar Disorder and also use marijuana. The goal is to see if Gabapentin can help balance certain chemicals in the brain that may be affected by both conditions. Participants in the study will be randomly assigned to take either Gabapentin or a placebo (a pill with no active ingredients) for 17 days. Throughout the trial, participants will have five study visits, which will include brain scans and assessments to monitor any side effects from the medication.

To be eligible for this study, participants need to be between 18 and 65 years old and meet specific criteria for both Bipolar Disorder and cannabis use disorder. They should also be willing to commit to taking the medication and attending follow-up appointments. During the trial, participants can expect to undergo regular check-ins, complete questionnaires, and have their brain activity measured through MRI scans. It's important to note that this study is currently recruiting participants, and those with certain health issues or who are taking specific medications may not qualify.

Gender

ALL

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)