A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid PTSD

N-乙酰半胱氨酸治疗酒精使用障碍和共病 PTSD 的随机对照试验

基本信息

  • 批准号:
    9329345
  • 负责人:
  • 金额:
    $ 55.69万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2016
  • 资助国家:
    美国
  • 起止时间:
    2016-08-10 至 2021-07-31
  • 项目状态:
    已结题

项目摘要

ABSTRACT Alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) are chronic and debilitating psychiatric conditions which frequently co-occur. If left untreated, individuals with AUD and co-occurring PTSD are at increased risk for developing other mental health problems (e.g., depression, anxiety), suicidal ideation and attempts, medical problems, family/relationship impairment, and employment problems. Despite the frequent co-occurrence and deleterious consequences associated with comorbid AUD/PTSD, there is little scientific evidence available to guide the provision of care. The proposed study directly addresses this critical knowledge gap by testing the efficacy of N-acetylcysteine (NAC) as compared to placebo in reducing AUD and PTSD severity. NAC represents a promising and novel candidate pharmacotherapy for individuals with AUD and comorbid PTSD. Accumulating preclinical and preliminary clinical research suggests a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. Data from a randomized, double-blind pilot study recently completed by the investigative team in Veterans with substance use disorders (primarily alcohol) and PTSD provides encouraging support for the therapeutic potential of NAC in the treatment of AUD and PTSD. Moreover, NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile, all of which confer ease of transferability from the research setting to clinical practice. In this Stage II study, we will (1) employ a two-arm randomized, double-blind, between-groups experimental design that will consist of 12 weeks of treatment with NAC or placebo medication; (2) use standardized, repeated dependent measures to rigorously assess AUD severity and PTSD symptomatology at 6 time points (baseline, week 6, week 12, and 3-, 6-, and 12-month follow-up); (3) measure impairment in associated mental and behavioral health problems (e.g., depression, sleep, suicidality, risky sexual behaviors, family/social functioning); and (4) use functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy (MRS) to investigate the underlying pathophysiology of comorbid AUD/PTSD and prognostic indicators of treatment outcome. To achieve these aims, we have assembled a multidisciplinary team of investigators with nationally-recognized expertise in AUD and comorbid PTSD, clinical trials, human laboratory paradigms, and neuroimaging who have successfully collaborated in the past and are uniquely qualified to implement this type of investigation. The proposed project is directly responsive to the mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the new AUD/PTSD initiative to accelerate research on the development of effective pharmacologic treatments for this common and highly disabling comorbidity. The findings from this study will provide critically needed empirical evidence to help inform clinical practice guidelines and accelerate research on the treatment of AUD and comorbid PTSD.
摘要

项目成果

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SUDIE E BACK其他文献

SUDIE E BACK的其他文献

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{{ truncateString('SUDIE E BACK', 18)}}的其他基金

Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial
认知处理疗法与酒精使用障碍和并发 PTSD 复发预防的整合:一项随机临床试验
  • 批准号:
    10934633
  • 财政年份:
    2023
  • 资助金额:
    $ 55.69万
  • 项目类别:
Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD
催产素可增强对同时发生的酒精使用障碍和创伤后应激障碍的综合暴露治疗
  • 批准号:
    10097893
  • 财政年份:
    2020
  • 资助金额:
    $ 55.69万
  • 项目类别:
Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD
催产素可增强对同时发生的酒精使用障碍和创伤后应激障碍的综合暴露治疗
  • 批准号:
    10262945
  • 财政年份:
    2020
  • 资助金额:
    $ 55.69万
  • 项目类别:
Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD
催产素可增强对同时发生的酒精使用障碍和创伤后应激障碍的综合暴露治疗
  • 批准号:
    10478268
  • 财政年份:
    2020
  • 资助金额:
    $ 55.69万
  • 项目类别:
Intelligent Biometrics to Optimize Prolonged Exposure Treatment for PTSD (IB-PE)
智能生物识别技术优化 PTSD 长期暴露治疗 (IB-PE)
  • 批准号:
    10018114
  • 财政年份:
    2019
  • 资助金额:
    $ 55.69万
  • 项目类别:
Intelligent Biometrics to Optimize Prolonged Exposure Treatment for PTSD (IB-PE)
智能生物识别技术优化 PTSD 长期暴露治疗 (IB-PE)
  • 批准号:
    9907260
  • 财政年份:
    2019
  • 资助金额:
    $ 55.69万
  • 项目类别:
Intelligent Biometrics to Optimize Prolonged Exposure Treatment for PTSD (IB-PE)
智能生物识别技术优化 PTSD 长期暴露治疗 (IB-PE)
  • 批准号:
    10083277
  • 财政年份:
    2019
  • 资助金额:
    $ 55.69万
  • 项目类别:
Randomized Controlled Trial of N-acetylcysteine for Alcohol Use Disorder and Comorbid PTSD
N-乙酰半胱氨酸治疗酒精使用障碍和共病 PTSD 的随机对照试验
  • 批准号:
    10209312
  • 财政年份:
    2016
  • 资助金额:
    $ 55.69万
  • 项目类别:
A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid PTSD
N-乙酰半胱氨酸治疗酒精使用障碍和共病 PTSD 的随机对照试验
  • 批准号:
    9982151
  • 财政年份:
    2016
  • 资助金额:
    $ 55.69万
  • 项目类别:
CAP - Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders
CAP - 多沙唑嗪治疗同时发生的 PTSD 和酒精使用障碍
  • 批准号:
    10039493
  • 财政年份:
    2015
  • 资助金额:
    $ 55.69万
  • 项目类别:

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  • 财政年份:
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高剂量对乙酰氨基酚与 n-乙酰半胱氨酸救援作为具有抗癌干细胞特性的新型 STAT3 抑制剂
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使用 N-乙酰半胱氨酸针对自闭症儿童限制性和重复性行为的神经生物学
  • 批准号:
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  • 财政年份:
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N-acetylcysteineの骨治癒促進効果の検討
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