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Recruiting NCT05064319

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

Phase II Interventional Bipolar Disorder Cannabis Use Schizoaffective Disorder, Bipolar Type Bipolar I Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gabapentin, Placebo.
Who it may be relevant to
Registry conditions: Bipolar Disorder, Cannabis Use, Schizoaffective Disorder, Bipolar Type, Bipolar I Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Gabapentin
    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.
  • Drug Placebo
    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.

Primary outcome measures

  • Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy [Time frame: Baseline to end of treatment, approximately 17 days]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medical University Of South Carolina — Charleston

Identifiers

NCT: NCT05064319 · 00112593 · R01DA054275

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗