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CompletedNCT05064319Updated Sep 9, 2026

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

A Phase 2 interventional study of Gabapentin and Placebo in Bipolar Disorder, Cannabis Use and Schizoaffective Disorder, Bipolar Type, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bipolar Disorder
  • Cannabis Use
  • Schizoaffective Disorder, Bipolar Type
  • Bipolar I Disorder
  • Bipolar II Disorder
  • Cannabis Use Disorder, Mild
  • Cannabis Use Disorder, Moderate
  • Cannabis Use Disorder, Severe
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 51 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Group A - Gabapentin

    Drug: Gabapentin

  • Placebo comparator
    Group B - Placebo

    Drug: Placebo

Interventions

  • DrugGabapentin

    After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive gabapentin 2-3 times a day for a total of 17 days.

  • DrugPlacebo

    After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive placebo 2-3 times a day for a total of 17 days.

06

What researchers measure

Primary outcomes

  1. Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy

    Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.

    Time frame: Baseline to end of treatment, approximately 17 days

07

Study locations

1 site
  • Medical University Of South Carolina
    Charleston, South Carolina 29425, United States
08

References and documents

Study documents

  • Informed consent form · Mar 30, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05064319
Lead sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
James Prisciandaro (Associate Professor, Medical University of South Carolina) — Principal investigator
First posted
Oct 1, 2021
Start date
Feb 24, 2022
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Sep 9, 2026

Study contacts

James J Prisciandaro, PhD
principal investigator · Medical University of South Carolina

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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