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：
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
项目类别：
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

项目摘要

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.

项目概要/摘要尽管与共病饮酒相关的情况经常同时发生并产生有害后果障碍（AUD）和创伤后应激障碍（PTSD），几乎没有科学证据可以指导提供护理。目前的研究通过测试功效直接解决了这一关键差距 N-乙酰半胱氨酸 (NAC) 与安慰剂相比，可降低 AUD 和 PTSD 严重程度。临床前积累临床研究为 NAC 在治疗以下疾病方面的治疗潜力提供了令人鼓舞的支持：通过谷氨酸能调节 AUD/PTSD。此外，NAC 是一种廉价的非处方药，具有良好的耐受性。家长资助是一项持续 12 周的双盲随机对照试验测试 NAC 与安慰剂在 AUD 症状（目标 1）和 PTSD 严重程度（目标 2）减轻方面的差异。先进的在治疗前和治疗后采用神经影像技术来研究疾病的病理生理学澳元/创伤后应激障碍（目标 3）。所有参与者每周接受 AUD 手动认知行为治疗 (CBT)。本行政补充文件 (PA-18-591) 的目的是保留高级博士后 Delisa Brown 博士研究员，在母项目上再工作六个月，以支持成功完成研究目标并维护母基金的完整性。布朗博士在该组织中担任两项重要且独特的职务由于 COVID-19 大流行造成的挫折，她担任这些职务的工作已被推迟。 (1) Brown 博士是一位训练有素的研究治疗师，每周通过远程医疗向参与者提供 AUD 的 CBT。她完成了为期多天的干预理论、背景和实施培训，并已近两年参加每周督导。布朗博士是一位杰出的临床医生，非裔美国临床医生，她为该项目带来了高度重视的多样性（样本中近 20% 是非洲人）美国人）。她以此身份开展的工作将有助于确保实现目标 1 和 2 所需的足够权力。 (2) Brown 博士通过进行意象脚本开发，在神经影像部分发挥着至关重要的作用创建个性化的扫描仪内酒精、创伤和中性线索的会话。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。她还协助完成成像数据预处理的关键任务，以确保质量控制和准备进行分析。她以这一身份所做的工作对于成功完成目标 3 至关重要。行政补充文件将确保布朗博士继续开展家长补助金工作，并维持执行这一重要项目的训练有素的团队的诚信。该项目的研究结果有创新临床实践、改善治疗结果并减少重大经济损失的潜力与同时发生的 AUD/PTSD 相关的负担。