COMBINING BEHAVIORAL TREATMENTS WITH AGONIST MAINTENANCE

这是我们的2x2研究的竞争性更新，评估了美沙酮与丁丙诺啡和社区强化方法(CRA)在合并阿片类药物和可卡因依赖患者治疗中的应用。数据分析显示，与丁丙诺啡相比，美沙酮的改善明显更大，CM的疗效有限，在代金券价值降至名义水平后，药物使用出现反弹。这项研究和其他研究中发现的使用阿片激动剂的CRA和CM的局限性包括：患者解决可卡因使用问题的动力不足；难以实施多方面和复杂的治疗；CM的疗效有限。因此，我们建议进行一项第一阶段的研究，用于手动开发和试点测试基于行为和社会学习理论的激动剂维持性阿片类药物和可卡因联合依赖患者的治疗，以解决这一人群中CRA和CM的几个弱点。这种治疗被称为治疗合同(TC)，结合了社区强化方法(CRA)的核心方面，与本研究中改善结果相关的核心方面，以及基于认知和社会学习理论的技术，可作为CM的替代方案，以增强患者的动力，克服士气低落，并提高目标实现。在这项拟议的研究中，我们计划首先改进TC，并在10名美沙酮维持的阿片和可卡因联合依赖患者的预试中为其开发个人治疗手册和培训材料。在试运行前，我们还计划开发TC遵从性和能力评级量表。随后，我们计划使用拆解设计进行一项试点研究，以比较TC和它的一个组成部分，手动指导的认知-行为应对技能疗法(CBT)。在试点中，将对3-5名治疗师进行培训，以实施每种治疗，患者将被随机分配到24周的TC或CBT中。主要结果措施包括减少非法阿片类药物和可卡因的使用，并通过每周三次尿毒学测试和自我报告来评估戒除情况。这项初步研究将被用来估计这两种治疗方法之间差异的潜在影响大小，并评估在更大的II阶段研究中比较TC和CBT的可行性。可行性将通过评估是否可以培训治疗师遵守手册并胜任地实施治疗；患者是否可以留在治疗中；以及治疗是否可以由盲目分配治疗的评分员可靠地区分出来进行评估。

This is a competing renewal of our 2x2 study evaluating methadone vs. buprenorphine and the Community Reinforcement Approach (CRA) with and without Contingency Management (CM) for the treatment of patients with concurrent opioid and cocaine dependence. Data analyses showed significantly greater improvements for methadone vs. buprenorphine and limited efficacy of CM, with a rebound in drug use after the value of the vouchers was reduced to a nominal level. Limitations of CRA and CM with opiate agonist maintained patients identified in this and other studies include the low motivation of patients to address problems of cocaine use; difficulties implementing the multifaceted and complex treatment; and the limited efficacy of CM. Therefore, we are proposing a Stage I study for manual development and pilot testing of a behavioral and social-learning theory based treatment for agonist maintained patients with combined opioid and cocaine dependence that addresses several weaknesses of CRA and CM in this population. This treatment, referred to as Therapeutic Contracting (TC), combines core aspects of the Community Reinforcement Approach (CRA) associated with improved outcome in the current study and cognitive and social learning theory based techniques which can serve as alternatives to CM for enhancing patients motivation, overcoming demoralization, and improving goal achievement. In the proposed study, we plan first to refine TC and develop an individual therapy manual and training materials for it during pre-pilot testing in 10 methadone maintained patients with combined opioid and cocaine dependence. During the pre-pilot, we also plan to develop TC adherence and competence rating scales. Subsequently, we plan to conduct a pilot study using a dismantling design to compare TC and one of its components, manual-guided cognitive-behavioral coping skills therapy (CBT). For the pilot, 3-5 therapists will be trained to administer each of the treatments and patients will be randomly assigned to 24 weeks of either TC or CBT. Primary outcome measures include reductions in illicit opioid and cocaine use and achievement of abstinence from them, as assessed by three times per week urine toxicology tests and self-report. The pilot study will be used to estimate the potential effect size of the difference between these two treatments and to evaluate the feasibility of comparing TC and CBT in a larger Stage II study. Feasibility will be evaluated by assessing whether therapists can be trained to adhere to the manuals and administer the treatments competently; whether patients can be retained in the treatments; and whether the treatments can be reliably discriminated by raters blinded to treatment assignment.