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
• 负责人: SUDIE E BACK
• 金额: $ 5.19万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10209312
• 关键词: Abstinence; Acetylcysteine; Address; Administrative Supplement; African American; Aftercare; Alcohol consumption; Alcohols; Animals; Antioxidants; Anxiety; Area; Biological; COVID-19 pandemic; Caring; Chronic Post Traumatic Stress Disorder; Clinical; Clinical Research; Cognitive Therapy; Complex; Cues; Data; Development; Disease; Double-Blind Method; Economic Burden; Ensure; Evidence based intervention; Functional Magnetic Resonance Imaging; Functional disorder; General Hospitals; Glutamates; Health Expenditures; Imagery; Impairment; Individual; Intervention; Investigation; Knowledge; Laboratories; Legal; Magnetic Resonance Spectroscopy; Massachusetts; Measurement; Measures; Medical Economics; Mental Depression; Methodology; Mission; National Institute on Alcohol Abuse and Alcoholism; Outcome; Participant; Patient Care; Patient Self-Report; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Placebos; Play; Post-Traumatic Stress Disorders; Postdoctoral Fellow; Preparation; Prognostic Marker; Protons; Public Health; Quality Control; Randomized; Randomized Controlled Trials; Research; Risk Behaviors; Role; Safety; Sampling; Science; Severities; Sleep; Standardization; Substance Use Disorder; Supervision; Symptoms; Techniques; Testing; Therapeutic; Therapeutic Agents; Training; Trauma; Treatment outcome; Universities; Veterans; Work; alcohol abuse therapy; alcohol comorbidity; alcohol use disorder; clinical practice; common treatment; comorbidity; craving; design; drinking; efficacy testing; evidence base; follow-up; image processing; improved; improved outcome; innovation; multidisciplinary; multimodality; neural circuit; neurobiological mechanism; neurochemistry; neuroimaging; parent grant; parent project; pilot trial; pre-clinical research; preservation; psychosocial; reduced alcohol use; response; suicide rate; symptomatology; telehealth; theories; treatment response

Project Summary/Abstract Despite the frequent co-occurrence and deleterious consequences associated with comorbid alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD), there is little scientific evidence available to guide the provision of care. The current study directly addresses this critical gap by testing the efficacy of N-acetylcysteine (NAC) as compared to placebo in reducing AUD and PTSD severity. Accumulating preclinical and clinical research provides encouraging support for the therapeutic potential of NAC in the treatment of AUD/PTSD via glutamatergic modulation. Moreover, NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile. The parent grant is an ongoing 12-week, double-blind, randomized controlled trial testing NAC versus placebo on reduction in AUD symptoms (Aim 1) and PTSD severity (Aim 2). Advanced neuroimaging techniques are employed at pre- and post-treatment to investigate the pathophysiology of AUD/PTSD (Aim 3). All participants receive weekly, manualized cognitive-behavioral therapy (CBT) for AUD. The purpose of this Administrative Supplement (PA-18-591) is to retain Dr. Delisa Brown, a senior postdoctoral fellow, on the parent project for an additional six months to support the successful completion of the study aims and preserve the integrity of the parent grant. Dr. Brown serves in two vital and distinct capacities on the project, and her work in these roles has been delayed due to setbacks resulting from the COVID-19 pandemic. (1) Dr. Brown is a highly-trained Study Therapist, providing weekly CBT for AUD via telehealth to participants. She completed a multi-day training on the intervention theory, background, and implementation, and has participated in weekly supervision over the past two years. Dr. Brown is an exceptional clinician, and as an African American clinician she brings highly valued diversity to the project (almost 20% of the sample is African American). Her work in this capacity will help ensure sufficient power necessary to address Aims 1 and 2. (2) Dr. Brown plays a vital role on the neuroimaging component by conducting imagery script development sessions to create personalized, in-scanner alcohol, trauma, and neutral cues. Dr. Brown completed specialized training at Yale University and Massachusetts General Hospital specifically for this purpose. She also assists with the critical task of pre-processing the imaging data to ensure quality control and preparation for analysis. Her work in this capacity is crucial to the successful completion of Aim 3. The requested Administrative Supplement will ensure Dr. Brown's continued work on the parent grant and maintain the integrity of the highly trained team carrying out this important project. The findings from this project have the potential to innovate clinical practice, improve treatment outcomes, and decrease the significant economic burden associated with co-occurring AUD/PTSD.

项目总结/摘要 尽管与共病酒精使用相关的常见并发症和有害后果 虽然有很多关于创伤后应激障碍（PTSD）的研究，但几乎没有科学证据可以指导 提供护理。目前的研究直接解决了这一关键差距，通过测试的有效性， 与安慰剂相比，N-乙酰半胱氨酸（NAC）降低AUD和PTSD严重程度。累积临床前 临床研究为NAC治疗以下疾病的治疗潜力提供了令人鼓舞的支持： AUD/PTSD通过神经递质调节。此外，NAC是一种廉价的非处方药， 良好的耐受性特征。父母补助金是一项正在进行的为期12周的双盲随机对照试验 测试NAC与安慰剂对AUD症状（目标1）和PTSD严重程度（目标2）的减轻。先进 在治疗前和治疗后采用神经成像技术来研究 AUD/PTSD（目标3）。所有参与者每周接受一次针对AUD的手动认知行为治疗（CBT）。 本行政补充（PA-18-591）的目的是保留博士Delisa布朗，高级博士后 研究员，在母项目上额外工作六个月，以支持成功完成研究目标 并保持父母补助金的完整性布朗博士担任两个重要和不同的能力， 由于COVID-19疫情导致的挫折，她在这些职位上的工作被推迟。 (1)Brown博士是一位训练有素的研究治疗师，每周通过远程医疗为参与者提供AUD的CBT。 她完成了关于干预理论、背景和实施的多日培训， 在过去的两年里，参加了每周的监督。布朗博士是一位杰出的临床医生， 非裔美国临床医生，她为项目带来了高度重视的多样性（近20%的样本是非洲人 美国）。她以这一身份开展的工作将有助于确保获得实现目标1和2所需的足够权力。 (2)布朗博士在神经影像学方面起着至关重要的作用，他负责指导图像脚本的开发。 会议，以创建个性化的，在扫描仪酒精，创伤，和中性线索。布朗博士完成 耶鲁大学和马萨诸塞州总医院专门为此目的进行了专门培训。她 还协助预处理成像数据的关键任务，以确保质量控制和准备 用于分析她以这一身份开展的工作对成功实现目标3至关重要。请求的 行政补充将确保布朗博士继续工作的父母补助金，并保持 执行这一重要项目的训练有素的团队的诚信。该项目的调查结果表明， 创新临床实践，改善治疗结果，减少重大经济损失的潜力 与合并发生的AUD/PTSD相关的负担。