NCT05064319CompletedPhase 2
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study
Medical University of South Carolina1 site in 1 country51 target enrollmentStarted: February 24, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 18-65 years
- •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
- •Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type
- •Able to provide informed consent and read, understand, and accurately complete assessment instruments
- •Willing to commit to medication treatment and follow-up assessments
- •Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)
Exclusion Criteria
- •A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
- •Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days
- •Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
- •Any history of brain injury with loss of consciousness greater than 5 minutes
- •Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
- •Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
- •Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
- •Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
- •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
- •Concomitant use of opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin
- •Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded
- •Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
- •Current suicidal or homicidal risk
- •Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
- •Has taken gabapentin in the last month or experienced adverse effects/allergic reaction (e.g., angioedema) from it at any time
- •Significant claustrophobia and/or past negative experiences with MRI
- •Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)
Arms & Interventions
Group A - Gabapentin
Experimental
Intervention: Gabapentin (Drug)
Group B - Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy
Time Frame: Baseline to end of treatment, approximately 17 days
Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.
Secondary Outcomes
No secondary outcomes reported
Investigators
James Prisciandaro
Associate Professor
Medical University of South Carolina
Study Sites (1)
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