CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Gabapentin +1 moredrug
Likely dose
Gabapentin 1,200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03334721
NCT03334721Phase 2Completed
CompareCT.gov

Gabapentin for Bipolar & Cannabis Use Disorders

Medical University of South Carolina·interventional·Posted Nov 7, 2017·Updated Nov 13, 2020

In Brief

A Phase 2 clinical trial evaluating Gabapentin and Placebo Oral Capsule for Bipolar I Disorder and 3 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder, Bipolar II Disorder, Cannabis Use Disorder, Substance Use Disorders
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 7, 2017
Enrollment StartOct 1, 2017
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago

Interventions

Gabapentindrug

5 day trial of gabapentin with titration to 1,200mg

Placebo Oral Capsuledrug

5 day trial of matched placebo