A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder

N-乙酰半胱氨酸治疗青少年酒精使用障碍的概念验证试验

基本信息

批准号：
9789787
负责人：
Kevin M Gray
金额：
$ 71.23万
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：
2018
资助国家：
美国
起止时间：
2018-09-22 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9789787
关键词：
18 year old Abstinence Acetylcysteine Addictive Behavior Adherence Adolescence Adolescent Adult Aftercare Age Agreement Alcohol abuse Alcohol consumption Alcohols Antioxidants Back Behavior Biological Biological Markers Clinical Clinical Trials Coupled Data Data Collection Development Double-Blind Method Evaluation Event Future Glucuronides Glutamates Healthcare Systems Heavy Drinking Homeostasis Measures Methodology Methods Mind Monitor National Institute on Alcohol Abuse and Alcoholism Outcome Patient Self-Report Pattern Pharmaceutical Preparations Pharmacological Treatment Pharmacotherapy Phase Placebos Procedures Public Health Randomized Controlled Trials Research Resistance Safety Self Administration Societies Standardization Substance Use Disorder System Testing Time TimeLine Treatment Efficacy Youth addiction adolescent alcohol treatment adolescents with alcohol use disorders adverse outcome age group alcohol use disorder alcohol use initiation base brief alcohol intervention carbohydrate-deficient transferrin cost design drinking effective therapy efficacy trial evidence base follow-up improved marijuana use disorder medication compliance meetings mobile computing phase III trial phosphatidylethanol pill preclinical study prevent randomized placebo controlled trial reduced alcohol use response therapy development underage drinking

项目摘要

ABSTRACT Adolescence marks a key period in the development of problematic alcohol use, with approximately 15% of 18 year olds meeting criteria for alcohol use disorder (AUD). Efforts to treat adolescent AUD have been only modestly effective, with up to 86% of youth returning to use within 12 months following treatment. Inadequate treatment for adolescents is an important public health concern given that alcohol use during this time is highly predictive of long-term problematic drinking. While several medications are efficacious in treating adult AUD, minimal pharmacotherapy research has focused on adolescents. Evaluation of alternative and more efficacious treatments for adolescents with AUD is warranted. The primary objective of the proposed Phase II proof-of- concept study is to evaluate the effect of N-acetylcysteine ( NAC), compared to placebo, in reducing alcohol use among treatment-seeking adolescents with AUD (N=120). Given NAC’s effect on addictive behaviors via glutamate modulation, accessibility as an over-the-counter supplement, safety and tolerability with adolescents, and low cost, this medication holds great promise as a potential treatment option for adolescents with AUD. In response to the National Institute on Alcohol Abuse and Alcoholism’s initiative to accelerate research on the development of effective pharmacologic treatments for AUD, we will (1) conduct an 8-week, intent-to-treat, double-blind, parallel-group, randomized, placebo-controlled trial of NAC (2400 mg per day); (2) examine standardized, repeated dependent measures of clinical outcomes at baseline, throughout treatment, and at post- treatment follow-up; and (3) employ mobile technology to improve data collection, engagement, and medication adherence. The identification of a well-tolerated, effective pharmacological treatment would represent a significant advance and could yield tremendous public health impact. The proposed trial will provide critical data to evaluate NAC as a pharmacotherapy for adolescent AUD, and regardless of NAC versus placebo outcomes will provide key methodological guidance for future randomized controlled trials of pharmacotherapies for adolescent AUD.

抽象的青春期标志着有问题的饮酒发展的关键时期，约有15％ 18岁的孩子符合酒精使用障碍标准（AUD）。高度有效，多达86％的年轻人在12个月内返回使用鉴于在时间时间期间的时间里，对青少年的治疗是一个重要的公共卫生问题预测长期饮酒，而严重性药物有效地治疗成人aud 最少的药物研究重点是青少年。有必要对青少年进行AUD的治疗。概念研究是为了评估N-乙酰半胱氨酸（NAC）与安慰剂相比的作用，以减少酒精在AUD（n = 120）中使用寻求治疗的青少年。谷氨酸调制，作为非处方药的可及性，对青少年的安全性和公差性，低成本，这种药物具有巨大的希望，作为AUD青少年的潜在治疗选择。对美国国家酒精滥用和酒精中毒研究所的回应，以加速研究开发有效的AUD药理学治疗方法，我们将（1）进行为期8周的意图处理，双盲，平行组，随机，安慰剂对照试验（每天2400 mg）；（2）检查在基线，THOOTHOUT治疗和后的标准化，重复依赖的临床结果量度治疗后续行动；依从性。具有重要的公共卫生影响，具有重要的公共卫生。评估NAC作为青少年AUD的药物治疗将为未来的药物治疗试验提供关键的方法论指导青少年aud。