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.
摘要
青少年是酒精使用问题发展的关键时期,大约15%的青少年
符合酒精使用障碍(AUD)标准的18岁青奥尔兹。治疗青少年AUD的努力仅限于
适度有效,高达86%的青少年在治疗后12个月内恢复使用。不足
青少年的治疗是一个重要的公共卫生问题,因为在这段时间内饮酒是非常重要的。
这预示着长期酗酒。虽然几种药物在治疗成人AUD中是有效的,
最低限度的药物治疗研究集中在青少年身上。评价替代方案,更有效
青少年AUD的治疗是必要的。第二阶段的主要目标是:
一项概念性研究是评估N-乙酰半胱氨酸(NAC)与安慰剂相比在减少饮酒方面的作用
在寻求治疗的AUD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获得性,青少年的安全性和耐受性,
而且成本低,这种药物作为青少年AUD的潜在治疗选择具有很大的希望。在
对国家酒精滥用和酒精中毒研究所关于加速研究酒精滥用和酒精中毒的倡议的回应
为了开发有效的AUD药物治疗,我们将(1)进行为期8周的意向治疗,
NAC(2400 mg/d)的双盲、平行组、随机、安慰剂对照试验;(2)检查
在基线、整个治疗期间和治疗后,
治疗随访;(3)采用移动的技术来改善数据收集、参与和用药
坚持。确定一种耐受性良好、有效的药物治疗将代表
这是一项重大进步,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
评价NAC作为青少年AUD的药物治疗,不考虑NAC与安慰剂的结局
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AUD
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
- 资助金额:
$ 72.5万 - 项目类别:
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