Gabapentin for Bipolar & Cannabis Use Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03334721|
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : July 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar I Disorder Bipolar II Disorder Cannabis Use Disorder Substance Use Disorders||Drug: Gabapentin Drug: Placebo Oral Capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Gabapentin for Bipolar & Cannabis Use Disorders|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||July 1, 2019|
|Actual Study Completion Date :||July 1, 2019|
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
5 day trial of gabapentin with titration to 1,200mg
Placebo Comparator: Placebo Oral Capsule
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Drug: Placebo Oral Capsule
5 day trial of matched placebo
- Prefrontal GABA and glutamate concentrations through Spectroscopy [ Time Frame: Day 5 of each experimental condition ]Concentrations of GABA and glutamate in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334721
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||James J Prisciandaro, PhD||Medical University of South Carolina|