N-Acetylcysteine for Bipolar and Alcohol Use Disorders
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.
調査の概要
詳細な説明
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 begins, and a safety visit within 72 hours after the day 28 visit. Study procedures include clinical interviews, self-report questionnaires, alcohol and drug assessments, blood and urine collection, and proton magnetic resonance spectroscopy and functional MRI. Treatment assignment details, intervention records, and outcome-measure records are intentionally left for study-team completion.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Sara Hix
- 電話番号：843-792-0572
- メール：hixs@musc.edu
研究場所
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
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コンタクト：
- Sara Hix
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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 Criteria:
- 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.
- 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.
- 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.
- NAC use in the last month or prior adverse effects from NAC.
- Has an allergy to riboflavin
- Significant claustrophobia or prior negative experience with MRI.
- Non-MRI-safe material in the body.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group A - N-Acetylcysteine
After group assignment but before taking any study medication, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive N-Acetylcysteine (NAC) 2 times a day for a total of 28 days. They will have follow up MRIs on day 14 and 28. |
28 days of NAC taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28 |
|
プラセボコンパレーター：Group B - Placebo
After group assignment but before taking any study medication, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group B will receive Placebo 2 times a day for a total of 28 days. They will have follow up MRIs on day 14 and 28. |
28 days of Placebo taken 2 times per day with MRI on days 1 (pre medication dosing), 14, and 28 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in dACC glutamate/glutathione levels through Proton Magnetic Resonance
時間枠：Baseline to end of treatment, approximately 28 days
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Concentrations of glutamate and glutathione in the dorsal anterior cingulate cortex will be measured on day 1, 14, and 28. |
Baseline to end of treatment, approximately 28 days
|
協力者と研究者
捜査官
- 主任研究者：James J. Prisciandaro, Ph.D.、Medical University of South Carolina
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Pro00153022
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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