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:10241372
- 负责人:
- 金额:$ 72.5万
- 依托单位:
- 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:
- 关键词:18 year oldAbstinenceAcetylcysteineAddictive BehaviorAdherenceAdolescenceAdolescentAdultAftercareAgeAgreementAlcohol abuseAlcohol consumptionAlcoholsAntioxidantsBackBehaviorBiologicalBiological MarkersClinical TrialsCoupledDataData CollectionDevelopmentDouble-Blind MethodEvaluationEventFutureGlucuronidesGlutamatesHealthcare SystemsHeavy DrinkingHomeostasisMeasuresMethodologyMethodsMindMonitorNational Institute on Alcohol Abuse and AlcoholismOutcomePatient Self-ReportPatternPharmaceutical PreparationsPharmacological TreatmentPharmacotherapyPhasePlacebosProceduresPublic HealthRandomized Controlled TrialsResearchResistanceSafetySelf AdministrationSocietiesStandardizationSubstance Use DisorderSystemTestingTimeTimeLineTreatment EfficacyYouthaddictionadolescent alcohol treatmentadolescents with alcohol use disordersadverse outcomeage groupalcohol use disorderalcohol use initiationbasebrief alcohol interventioncarbohydrate-deficient transferrinclinical outcome measurescostdesigndrinkingeffective therapyefficacious treatmentefficacy outcomesefficacy trialevidence basefollow-upimprovedmarijuana use disordermedication compliancemeetingsmobile computingphase III trialphosphatidylethanolpillpreclinical studypreventrandomized placebo controlled trialreduced alcohol useresponsetherapy developmentunderage 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
青春期是酗酒问题发展的关键时期,大约 15%
符合酒精使用障碍 (AUD) 标准的 18 岁青少年。治疗青少年 AUD 的努力仅
效果中等,高达 86% 的青少年在治疗后 12 个月内恢复使用。不足
鉴于青少年时期饮酒的比例很高,因此对青少年的治疗是一个重要的公共卫生问题
预测长期饮酒问题。虽然有几种药物可以有效治疗成人 AUD,
最低限度的药物治疗研究主要集中在青少年。评估替代方案和更有效的方案
对患有 AUD 的青少年进行治疗是有必要的。拟议的第二阶段证明的主要目标是
概念研究旨在评估 N-乙酰半胱氨酸 (NAC) 与安慰剂相比在减少酒精摄入方面的效果
在患有 AUD 的寻求治疗的青少年中使用(N = 120)。鉴于 NAC 对成瘾行为的影响
谷氨酸调节、作为非处方补充剂的可及性、青少年的安全性和耐受性,
而且成本低廉,这种药物作为青少年 AUD 的潜在治疗选择具有广阔的前景。在
响应国家酒精滥用和酒精中毒研究所加速研究的倡议
为了开发 AUD 的有效药物治疗方法,我们将 (1) 进行为期 8 周的意向治疗,
NAC(每天 2400 毫克)的双盲、平行组、随机、安慰剂对照试验; (2)检查
在基线、整个治疗过程中以及治疗后对临床结果进行标准化、重复的依赖性测量
治疗随访; (3) 采用移动技术来改善数据收集、参与和药物治疗
坚持。确定一种耐受性良好、有效的药物治疗方法将代表
重大进展,可能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,并且不考虑 NAC 与安慰剂的结果
将为未来的药物治疗随机对照试验提供关键的方法学指导
青少年澳元。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Kevin M Gray其他文献
Nicotine Therapy Sampling to Induce Quit Attempts Among Smokers Unmotivated to Quit
尼古丁治疗取样以诱导无戒烟动机的吸烟者尝试戒烟
- DOI:
- 发表时间:
2016 - 期刊:
- 影响因子:0
- 作者:
M. Carpenter;John R. Hughes;Kevin M Gray;A. Wahlquist;M. Saladin;A. Alberg - 通讯作者:
A. Alberg
Kevin M Gray的其他文献
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{{ truncateString('Kevin M Gray', 18)}}的其他基金
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:
10480914 - 财政年份:2018
- 资助金额:
$ 72.5万 - 项目类别:
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 - 财政年份:2018
- 资助金额:
$ 72.5万 - 项目类别:
13/21 ABCD-USA CONSORTIUM: RESEARCH PROJECT SITE AT MUSC
13/21 ABCD-美国联盟:MUSC 研究项目现场
- 批准号:
10596593 - 财政年份:2017
- 资助金额:
$ 72.5万 - 项目类别:
N-Acetylcysteine and Contingency Management for Youth Cannabis Use Disorder
N-乙酰半胱氨酸和青少年大麻使用障碍的应急管理
- 批准号:
9156301 - 财政年份:2017
- 资助金额:
$ 72.5万 - 项目类别:
N-Acetylcysteine and Contingency Management for Youth Cannabis Use Disorder
N-乙酰半胱氨酸和青少年大麻使用障碍的应急管理
- 批准号:
10087909 - 财政年份:2017
- 资助金额:
$ 72.5万 - 项目类别:
13/21 ABCD-USA CONSORTIUM: RESEARCH PROJECT SITE AT MUSC
13/21 ABCD-美国联盟:MUSC 研究项目现场
- 批准号:
9981294 - 财政年份:2017
- 资助金额:
$ 72.5万 - 项目类别:
13/21 ABCD-USA CONSORTIUM: RESEARCH PROJECT SITE AT MUSC
13/21 ABCD-美国联盟:MUSC 研究项目现场
- 批准号:
10379329 - 财政年份:2017
- 资助金额:
$ 72.5万 - 项目类别:
Advancing Varenicline as a Treatment for Cannabis Use Disorder
推进伐尼克兰治疗大麻使用障碍
- 批准号:
9249775 - 财政年份:2016
- 资助金额:
$ 72.5万 - 项目类别:
Advancing Varenicline as a Treatment for Cannabis Use Disorder
推进伐尼克兰治疗大麻使用障碍
- 批准号:
10202536 - 财政年份:2016
- 资助金额:
$ 72.5万 - 项目类别:
Advancing Varenicline as a Treatment for Cannabis Use Disorder
推进伐尼克兰治疗大麻使用障碍
- 批准号:
10004604 - 财政年份:2016
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$ 72.5万 - 项目类别:
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