Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05064319|
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : July 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bipolar 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||Drug: Gabapentin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study|
|Actual Study Start Date :||February 24, 2022|
|Estimated Primary Completion Date :||June 30, 2026|
|Estimated Study Completion Date :||June 30, 2026|
|Experimental: Group A - Gabapentin||
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 Comparator: Group B - Placebo||
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.
- Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy [ Time Frame: Baseline to end of treatment, approximately 17 days ]Concentrations of GABA, normalized to water and corrected for CSF%, 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): NCT05064319
|Contact: Sara Hixemail@example.com|
|United States, South Carolina|
|Medical University Of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Sara Hix 843-792-0572 firstname.lastname@example.org|
|Principal Investigator: James J Prisciandaro, PhD|
|Principal Investigator:||James J Prisciandaro, PhD||Medical University of South Carolina|