Maximizing CBT's Efficacy with Medication & CM

描述（由申请人提供）： 我们在过去十年中的工作已经确立了认知行为疗法（CBT）单独或与药物联合治疗可卡因依赖的疗效。现在重要的是探索CBT的结果可以最大化的程度。新出现的证据表明，通过会话之外的应对技能的实践获得技能，促进CBT更好的结果;因此，促进完成家庭作业任务的策略可能会改善CBT的结果。此外，通过最近一系列随机双盲对照试验，双硫仑已被证明可显著减少可卡因的使用，特别是与CBT联合使用。然而，缺乏依从性会削弱双硫仑的有效性。应急管理（CM）方法本身作为可卡因使用障碍的行为干预措施非常有效，并可用于促进其他目标行为，如遵守其他治疗。CM尚未被探索作为一种策略，以提高结果，促进坚持CBT或双硫仑治疗可卡因依赖。第二阶段试验的具体目标是：首先，使用2x2析因模型，对160名可卡因依赖门诊患者进行为期12周的随机临床试验，评估CBT与以下药物联合治疗的疗效：（1）安慰剂，（2）双硫仑，（3）安慰剂+CM，或（4）双硫仑+CM。第二，通过1年随访，评价研究治疗终止后治疗效果的长期持久性和/或延迟出现。主要结果将是自我报告的可卡因使用情况（每周戒断天数）和每周三次尿液毒理学筛查的结果。将通过核黄素示踪程序监测双硫仑治疗的依从性。行为治疗将由人工指导，并监测治疗师的技能和对人工指南的遵守情况。研究治疗停止后1、3、6、9和12个月的随访将评估治疗效果的持久性和/或延迟出现。在治疗期间每月评估一次评估理论作用机制的变量。

DESCRIPTION (provided by applicant): Our work during the past ten years has established the efficacy of cognitive-behavioral therapy (CBT), alone and in combination with medication, for cocaine dependence. It is now important to explore the extent to which outcomes for CBT can be maximized. Emerging evidence suggests that acquisition of skills through practice of coping skills outside of sessions facilitates better outcomes in CBT; thus, strategies that facilitate completion of homework tasks are likely to improve outcomes in CBT. In addition, disulfiram has been demonstrated through a recent series of randomized double blind controlled trials to significantly reduce cocaine use, particularly in combination with CBT. However, lack of adherence can undercut the effectiveness of disulfiram. Contingency management (CM) approaches are highly effective in their own right as behavioral interventions for cocaine use disorders and can be used to promote other target behaviors, such as compliance with other therapies. CM has not yet been explored as a strategy to enhance outcomes by promoting adherence to CBT or to disulfiram treatment of cocaine dependence. Specific aims for this Stage II trial are: First, to conduct a 12 week randomized clinical trial, using a 2x2 factorial model, with 160 cocaine dependent outpatients, that will evaluate the efficacy of CBT in combination with either: (1)placebo, (2) disulfiram, (3)placebo plus CM, or (4) disulfiram plus CM. Second, to evaluate the long-term durability and/or delayed emergence of treatment effects after termination of the study treatments through a one-year follow-up. The primary outcomes will be self-reported cocaine use (days of abstinence by week), and results of thrice weekly urine toxicology screens. Compliance with disulfiram treatment will be monitored by the riboflavin tracer procedure. Behavioral treatments will be manual-guided and monitored for therapist skill and adherence to manual guidelines. Follow-ups at 1, 3, 6, 9 and 12 months after cessation of study treatment will assess the durability and/or delayed emergence of treatment effects. Variables assessing theoretical mechanisms of action will be assessed monthly during treatment.