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
- Diseases
- Bipolar disorder
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.