TSF to enhance treatment of cocaine dependence

可卡因的使用在大多数美沙酮维持计划中仍然很流行，并且与许多并发问题有关，特别是静脉注射吸毒和艾滋病毒的高风险。在这种情况下，双硫仑是一种很有希望的治疗可卡因滥用的方法，但这种效果必须用更大的样本来复制。此外，评估双硫仑的有效性是否可以通过增加更有效的心理治疗方法来增强是至关重要的。手动十二步促进（TSF）是一种很有前途但研究不足的心理治疗方法，值得进一步的实证评估。拟议的2X2设计将允许评估TSF作为标准美沙酮维持的辅助手段，以及它与双硫仑联合使用的益处。在这项II期研究中，180名可卡因依赖美沙酮维持的阿片类药物成瘾者将被随机分配到四种治疗方法中的一种：(1)十二步促进（TSF）加上标准美沙酮咨询加双硫仑，(2)十二步促进（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。研究治疗将在手册指导下进行，持续12周。主要结果将是减少可卡因的使用，通过自我报告评估，并通过每周三次的尿检证实。第二个结果将包括减少非法阿片类药物和酒精的使用，以及改善社会心理功能。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，以防止在研究过程中发生漂移。每周收集三次受监督的尿液。所有的咨询过程都将录像，以供治疗师监督和过程评估。在研究治疗停止后1、3、6、9和12个月的随访将评估治疗效果的持久性和/或延迟出现的时间。

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.