Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics
|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: NCT03220776|
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : March 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder Bipolar Disorder||Drug: N-Acetylcysteine Drug: Gabapentin Drug: Placebo Oral Tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Imaging Framework for Testing GABAergic/Glutamatergic Drugs in Bipolar Alcoholics|
|Actual Study Start Date :||August 7, 2017|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||April 30, 2022|
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., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
5 day trial of N-acetylcysteine with titration to 2,400mg
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 Tablet
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 Tablet
5 day trial of matched placebo
- Prefrontal GABA and glutamate concentrations [ 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): NCT03220776
|Contact: James J Prisciandaro, Ph. D||(843) email@example.com|
|Contact: Sara Hixfirstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: James J Prisciandaro, PhD 843-792-1433 email@example.com|
|Principal Investigator: James Prisciandaro, PhD|
|Sub-Investigator: Kevin Gray, MD|
|Sub-Investigator: Truman Brown, PhD|
|Sub-Investigator: Will Mellnick, PhD|
|Sub-Investigator: Bryan Tolliver, PhD|
|Sub-Investigator: Raymond Anton, MD|
|Principal Investigator:||James J Prisciandarao, Ph. D||Medical University of South Carolina|