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

ConditionsBipolar 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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Gabapentin
Drug
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.
Placebo
Drug
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.

Treatment groups

68 Participants

are divided into 2 treatment groups

Group A: Group A - GabapentinExperimental treatment 1 intervention

Group B: Group B - PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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