COMBINING BEHAVIORAL TREATMENTS WITH AGONIST MAINTENANCE

这是我们的2x2研究的竞争更新，评估美沙酮与丁丙诺啡以及社区强化方法（CRA）在有或没有应急管理（CM）的情况下治疗阿片类药物和可卡因同时依赖的患者。数据分析显示，美沙酮与丁丙诺啡相比有更大的改善，而CM的疗效有限，在代金券的价值降低到名义水平后，药物使用有所反弹。本研究和其他研究中确定的维持阿片激动剂的患者的CRA和CM的局限性包括患者解决可卡因使用问题的动机低；实施多方面复杂治疗的困难；中药疗效有限。因此，我们建议进行一项I期研究，对阿片类药物和可卡因联合依赖的激动剂维持患者进行基于行为和社会学习理论的治疗，以手工开发和试点测试，以解决该人群中CRA和CM的几个弱点。这种治疗被称为治疗收缩（TC），结合了社区强化方法（CRA）的核心方面，与当前研究中改善的结果相关，以及基于认知和社会学习理论的技术，这些技术可以作为CM的替代方案，增强患者的动机，克服士气低落，提高目标的实现。在拟议的研究中，我们计划首先在10名阿片类药物和可卡因联合依赖的美沙酮维持患者中进行预试验，完善TC并为其开发个体治疗手册和培训材料。在预试点阶段，我们还计划开发TC依从性和能力评定量表。随后，我们计划进行一项试点研究，使用拆解设计来比较TC及其组成部分之一，即手动引导的认知行为应对技能疗法（CBT）。在试点中，将培训3-5名治疗师来管理每种治疗方法，患者将被随机分配到24周的TC或CBT。主要结果措施包括减少非法阿片类药物和可卡因的使用，并实现戒断，通过每周三次尿液毒理学测试和自我报告进行评估。该初步研究将用于估计这两种治疗之间差异的潜在效应大小，并评估在更大规模的II期研究中比较TC和CBT的可行性。可行性将通过评估治疗师是否能够接受培训以遵守手册并有效地实施治疗来评估；患者是否能留在治疗中；以及对治疗分配不知情的评分者能否可靠地区分治疗。

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.