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NCT05064319CompletedPhase 2

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

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
51 (actual)
First submitted
22 Sept 2021
Start date
24 Feb 2022
Primary completion date
31 Jul 2026
Lead sponsor
Medical University of South Carolina
NCT number
NCT05064319

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 51
  • From 24 Feb 2022 to the primary completion date, 31 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded
  • Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)

Other illness

  • 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
  • Has taken gabapentin in the last month or experienced adverse effects/allergic reaction (e.g., angioedema) from it at any time

Lab values

  • 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 opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin

Other

  • 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
  • Significant claustrophobia and/or past negative experiences with MRI

Who the study is looking for

  • 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)

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.