Testing N-acetylcysteine for Bipolar and Alcohol Use Disorders
Tests N-acetylcysteine against a placebo in adults with bipolar disorder and heavy drinking.
Plain-language title generated from the registry record
Registry title: N-Acetylcysteine for Bipolar and Alcohol Use Disorders
Key facts
- Where
- Charleston, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07913542, who can take part
Where in United States
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of South Carolina
- Trial code
- NCT07913542
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
N-acetylcysteine for Restoring Glutamate/Glutathione Homeostasis and Reducing Heavy Drinking in Co-occurring Bipolar and Alcohol Use Disorders
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.
Inclusion: Age 18 to 60 years; Meet DSM-5 criteria for bipolar I or bipolar II disorder; Prescribed daily use of at least one FDA-approved mood-stabilizing medication (lithium, divalproex sodium, lamotrigine, or a second-generation antipsychotic); Meet DSM-5 criteria for current, within the past 90 days, moderate to severe alcohol use disorder; Active alcohol use in the past 14 days, with heavy drinking days on at least 50% of drinking days in the past 30 days; Able to provide informed consent and read, understand, and accurately complete assessment instruments; Willing to commit to medication treatment and follow-up assessments; Willing to abstain from antioxidant supplements for the duration of the study.
Exclusion: Concomitant use of nitroglycerin, carbamazepine, or another medication deemed hazardous with NAC; Concomitant use of specified alcohol-use-disorder medications or medications that could interfere with glutamate transmission; Electroconvulsive therapy in the past 3 months; Medication dose change of 20% or greater within 2 weeks before testing; NAC use in the last month or prior adverse effects from NAC; Significant claustrophobia or prior negative experience with MRI; Primary psychiatric diagnosis other than bipolar disorder; Uncontrolled neurological condition that could confound study results; History of brain injury with loss of consciousness greater than 5 minutes; History of intellectual disability or dementia; Uncontrolled medical condition that may adversely affect study conduct or participant safety; Hepatocellular disease as defined in the protocol; Renal insufficiency as defined in the protocol; Has an allergy to riboflavin; Pregnancy, lactation, or refusal to use adequate contraception when applicable; Current suicidal or homicidal risk; Baseline MADRS score greater than 35 or YMRS score greater than 25; Clinically significant alcohol withdrawal symptoms or autonomic instability; Non-MRI-safe material in the body.