Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world.
Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: an efficacy trial conducted in the real world.
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DOI：
10.1016/j.cct.2012.05.003
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发表时间：
2012-09
影响因子：
2.2
通讯作者：
Somoza E
中科院分区：
文献类型：
--
作者：
Winhusen T;Brady KT;Stitzer M;Woody G;Lindblad R;Kropp F;Brigham G;Liu D;Sparenborg S;Sharma G;Vanveldhuisen P;Adinoff B;Somoza E
可卡因依赖是一个重要的公共卫生问题，目前没有FDA批准的药物。因此，确定候选化合物并采用有效的评估过程至关重要。本文描述了美国国家药物滥用研究所（NIDA）临床试验网络（CTN）研究的关键设计决策，该研究使用一种新的两阶段方法来评估丁螺环酮（60 mg/天）预防可卡因复发。该研究包括试点（N=60）和全面（估计N=264）试验。这两项试验都是随机、双盲和安慰剂对照的，都将招募寻求治疗的可卡因依赖参与者，他们参与住院/住院治疗，并计划在出院后接受门诊治疗。所有参与者都将接受应急管理，根据药物事件监测系统（MEMS）的评估，为药物依从性提供激励。主要结果测量是在15周的门诊治疗期内，通过每周两次的尿液药物筛查（UDS）和自我报告评估的连续可卡因戒断的最大天数。药物滥用结果包括UDS评估的可卡因使用和可卡因使用的自我报告，UDS评估的其他物质使用和物质使用的自我报告（即，酒精和/或非法药物），可卡因狂欢，艾滋病毒风险行为，生活质量，功能和物质滥用治疗出勤率。该研究的独特方面包括在社区治疗计划中进行疗效试验，有效评估丁螺环酮的两阶段过程，以及评估丁螺环酮可能对复发预防产生有益影响的介质。
Cocaine dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60 mg/day) for cocaine-relapse prevention. The study includes pilot (N=60) and full-scale (estimated N=264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include cocaine use as assessed by UDS and self-report of cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance-abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention.
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影响因子：
7.6
作者：
BARON, RM;KENNY, DA
通讯作者：
KENNY, DA
DOI：
10.1016/j.pbb.2011.04.017
发表时间：
2011-08
期刊：
Pharmacology, biochemistry, and behavior
影响因子：
--
作者：
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通讯作者：
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作者：
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通讯作者：
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影响因子：
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作者：
Carpenter, KM;Schreiber, E;McDowell, D
通讯作者：
McDowell, D
影响因子：
6.9
作者：
Harper, A;Power, M
通讯作者：
Power, M