Phase 2 N=23 Randomized Quadruple-blind Basic Science

Gabapentin for Bipolar & Cannabis Use Disorders

Bipolar I Disorder · Bipolar II Disorder · Cannabis Use Disorder · Substance Use Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03334721 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy — 2.625; 2.696; 2.609; 2.720 Institutional Units — p=0.711

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Gabapentin (Drug); Placebo Oral Capsule (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy	2.625; 2.696; 2.609; 2.720	0.711

Summary

The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate medication-related changes in response inhibition (go no-go) and cannabis cue reactivity functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms (including anxiety and sleep), and impulsivity in individuals with CUD+BD.

Eligibility Criteria

Inclusion Criteria

Meets DSM-V criteria for Bipolar Disorder
Meets DSM-V criteria for Cannabis Use Disorder
Using at least one mood stabilizing medication

Exclusion Criteria

Serious medical or non-inclusionary psychiatric disease
Concomitant use of benzodiazepine medications or any medications hazardous if taken with gabapentin
History of clinically significant brain injury
Presence of non-MRI safe material, or clinically significant claustrophobia.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03334721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.