Maximizing CBT's Efficacy with Medication & CM

通过药物最大限度地提高 CBT 的功效

• 批准号: 7059940
• 负责人: KATHLEEN M. CARROLL
• 金额: $ 34.43万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-04-25 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7059940
• 关键词: behavior modification; behavioral /social science research tag; breath tests; clinical research; clinical trial phase II; cocaine; cognitive behavior therapy; combination therapy; coping; disulfiram; drug abuse chemotherapy; drug addiction; high risk behavior /lifestyle; human subject; human therapy evaluation; longitudinal human study; patient oriented research; therapy compliance; urinalysis

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.

描述（由申请人提供）： 在过去的十年中，我们的工作确立了与可卡因依赖性相关的认知行为疗法（CBT）（CBT）（CBT）的功效。现在，重要的是要探索可以最大化CBT结果的程度。新兴的证据表明，通过应对会议之外的应对技能的练习获得了技能，这促进了CBT的更好结果。因此，有助于完成家庭作业任务的策略可能会改善CBT的结果。此外，最近通过一系列随机双盲对照试验证明了二硫仑，以大大降低可卡因的使用，尤其是与CBT结合使用。但是，缺乏依从性会降低二硫酸的有效性。作为可卡因使用障碍的行为干预措施，应急管理（CM）方法本身具有非常有效的措施，可用于促进其他目标行为，例如遵守其他疗法。 CM尚未作为一种通过促进CBT依从性或对可卡因依赖性的二硫酸治疗来提高结果的策略。该阶段II试验的具体目的是：首先，使用2x2阶乘模型进行12周的随机临床试验，具有160个可卡因依赖性门诊病人，该试验将评估CBT与任何一个结合使用：（1）安慰剂，（1）disulfiram，（2）Disulfiram，（3）安慰剂加上CM，或（4）disulfiram plus cm。其次，通过一年的随访评估研究治疗终止治疗后的长期耐用性和/或延迟出现。主要结果将是自我报告的可卡因使用（每周禁欲的日子）和每周三次尿液毒理学筛查的结果。核黄素示踪剂程序将监测对二硫仑治疗的依从性。行为治疗将是手动引导的，并监测治疗师的技能和遵守手动指南。停止研究治疗后1、3、6、9和12个月的随访将评估治疗效果的耐用性和/或延迟出现。评估理论机制的变量将在治疗期间每月评估。