TSF to enhance treatment of cocaine dependence

TSF 加强可卡因依赖治疗

• 批准号: 6495092
• 负责人: KATHLEEN CARROLL
• 金额: $ 17.92万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6495092
• 关键词: behavioral /social science research tag; clinical research; cocaine; counseling; disulfiram; drug abuse therapy; drug addiction; endogenous opioid; human subject; human therapy evaluation; methadone; placebos; psychotherapy; urinalysis

Cocaine use remains epidemic among most methadone maintenance programs and is associated with a host of concurrent problems, particularly higher risk of intravenous drug use and HIV. Disulfiram is a promising treatment for cocaine abuse in this setting, but this effect must be replicated with a larger sample. Moreover, it is critical to evaluate whether disulfiram's effectiveness can be enhanced though adding a more potent psychotherapeutic approach. Manualized Twelve-Step Facilitation (TSF) is a promising but understudied psychotherapeutic approach worthy of extended empirical evaluation. The proposed 2X2 design will permit evaluation of TSF as adjunct to standard methadone maintenance as well as its benefits in combination with disulfiram. In this Stage II study, 180 cocaine-dependent methadone-maintained opioid addicts will be assigned, using urn randomization, to one of four treatments: (1) Twelve-Step Facilitation (TSF) in addition to standard methadone counseling plus disulfiram, (2) Twelve-Step Facilitation (TSF) plus placebo, (3) Standard methadone counseling plus disulfiram, or (4) Standard methadone counseling plus placebo. Study treatments will be manual-guided and will last 12 weeks. The primary outcome will be reduction in cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalysis. Second outcomes will include reductions in illicit opioid and alcohol use, as well as improvements in psychosocial functioning. Treatments will be delivered by experienced clinicians, who will receive training and ongoing supervision to prevent drift during the course of the study. Supervised urines will be collected thrice weekly. All counseling sessions will be videotaped for ongoing therapist supervision and process assessment. Follow-ups at 1,3, 6, 9 and 12 months after cessation of study treatments will assess the durability and/or delayed emergence of treatment effects.

在大多数美沙酮维持治疗项目中，可卡因的使用仍然是流行病，并与一系列并发问题有关，特别是静脉注射毒品和艾滋病毒的风险更高。双硫仑是一种很有前途的治疗可卡因滥用在这种情况下，但这种效果必须复制一个更大的样本。此外，通过增加更有效的心理治疗方法来评估双硫仑的有效性是否可以提高是至关重要的。手动跨步骤引导（TSF）是一种有前途但研究不足的心理治疗方法，值得扩展的实证评估。拟议的2X2设计将允许评价TSF作为标准美沙酮维持治疗的辅助治疗及其与双硫仑联合治疗的获益。在第二阶段的研究中，180名可卡因依赖的美沙酮维持阿片类药物成瘾者将被随机分配到四种治疗中的一种：（1）在标准美沙酮咨询加双硫仑的基础上进行双步骤促进（TSF），（2）双步骤促进（TSF）加安慰剂，（3）标准美沙酮咨询加双硫仑，或（4）标准美沙酮咨询加安慰剂。研究治疗将采用手动指导，持续12周。主要结果将是可卡因使用的减少，通过自我报告进行评估，并通过每周三次尿分析进行确认。第二个成果将包括减少非法阿片类药物和酒精的使用，以及改善心理社会功能。治疗将由经验丰富的临床医生提供，他们将接受培训和持续监督，以防止研究过程中的漂移。将每周收集三次受监督的尿液。所有的咨询课程都将被录像，以供治疗师持续监督和过程评估。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。