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

• 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
• 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

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 青少年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）。治疗青少年aud的努力只是 适度有效，多达86％的年轻人在治疗后的12个月内返回使用。不足 鉴于这段时间的饮酒是高度的，对青少年的治疗是一个重要的公共卫生问题 可以预测长期饮酒的问题。虽然几种药物有效地治疗成人aud，但 最少的药物治疗研究集中在青少年上。评估替代性和更有效的 有必要为青少年使用AUD治疗。提议的II期证明的主要目标 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。鉴于NAC通过 谷氨酸调制，作为非处方补充剂的可访问性，青少年的安全性和耐受性， 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。在 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药物治疗方法，我们将（1）进行8周的意图处理， NAC的双盲，平行组，随机，安慰剂对照试验（每天2400 mg）； （2）检查 在基线，整个治疗过程中和之后，标准化的，重复依赖的临床结果量度 治疗随访； （3）员工移动技术以改善数据收集，参与和药物 坚持。识别良好，有效的药物治疗将代表 巨大的进步，可能会产生巨大的公共卫生影响。拟议的试验将提供关键数据 评估NAC作为青少年AUD的药物疗法，无论NAC与安慰剂结果如何 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。