Phase 2
Completed N=23
Gabapentin for Bipolar & Cannabis Use Disorders
Source: ClinicalTrials.gov NCT03334721 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy — 2.625; 2.696; 2.609; 2.720 Institutional Units — p=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.
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 |
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.
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. Informational only — not medical advice.