Medical University of South Carolina
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.
This randomized, placebo-controlled, double-blind, parallel-group mechanistic clinical trial will evaluate adjunctive N-acetylcysteine (NAC) in adults with co-occurring bipolar disorder and alcohol use disorder. The study is designed to examine whether NAC changes dorsal anterior cingulate cortex glutamate and glutathione homeostasis and brain activation to alcohol cues, and whether those changes are associated with reductions in heavy drinking and depressive symptoms. Participants will complete a baseline evaluation, a pretreatment MRI visit, MRI visits at 14 and 28 days after treatment begin…
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.…
28 days of NAC taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28
28 days of Placebo taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28
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