Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07913542

PHASE2

N-Acetylcysteine for Bipolar and Alcohol Use Disorders

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

Summary

This study will evaluate N-acetylcysteine (NAC) in adults with bipolar disorder and alcohol use disorder. Participants will be randomly assigned to receive NAC or matched placebo for 28 days. The study includes five visits and three MRI brain imaging scans. Questionnaires, clinical interviews, alcohol and drug assessments, laboratory testing, and monitoring for possible side effects will be completed during study visits.

Official title: N-acetylcysteine for Restoring Glutamate/Glutathione Homeostasis and Reducing Heavy Drinking in Co-occurring Bipolar and Alcohol Use Disorders

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-01-01

Completion Date

2031-08-31

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Bipolar Disorder Alcohol Use Disorder

Interventions

DRUG

N-acetyl cysteine

28 days of NAC taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28

DRUG

Placebo

28 days of Placebo taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28

Inclusion Criteria: 1. Age 18 to 60 years. 2. Meet DSM-5 criteria for bipolar I or bipolar II disorder. 3. Prescribed daily use of at least one FDA-approved mood-stabilizing medication (lithium, divalproex sodium, lamotrigine, or a second-generation antipsychotic). 4. Meet DSM-5 criteria for current, within the past 90 days, moderate to severe alcohol use disorder. 5. Active alcohol use in the past 14 days, with heavy drinking days on at least 50% of drinking days in the past 30 days. 6. Able to provide informed consent and read, understand, and accurately complete assessment instruments. 7. Willing to commit to medication treatment and follow-up assessments. 8. Willing to abstain from antioxidant supplements for the duration of the study. Exclusion Criteria: 1. Primary psychiatric diagnosis other than bipolar disorder. 2. Uncontrolled neurological condition that could confound study results. 3. History of brain injury with loss of consciousness greater than 5 minutes. 4. History of intellectual disability or dementia. 5. Uncontrolled medical condition that may adversely affect study conduct or participant safety. 6. Hepatocellular disease as defined in the protocol. 7. Renal insufficiency as defined in the protocol. 8. Concomitant use of nitroglycerin, carbamazepine, or another medication deemed hazardous with NAC. 9. Concomitant use of specified alcohol-use-disorder medications or medications that could interfere with glutamate transmission. 10. Electroconvulsive therapy in the past 3 months. 11. Medication dose change of 20% or greater within 2 weeks before testing. 12. Pregnancy, lactation, or refusal to use adequate contraception when applicable. 13. Current suicidal or homicidal risk. 14. Baseline MADRS score greater than 35 or YMRS score greater than 25. 15. Clinically significant alcohol withdrawal symptoms or autonomic instability. 16. NAC use in the last month or prior adverse effects from NAC. 17. Has an allergy to riboflavin 18. Significant claustrophobia or prior negative experience with MRI. 19. Non-MRI-safe material in the body.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States