COMBINING BEHAVIORAL TREATMENTS WITH AGONIST MAINTENANCE

这是我们的2x2研究的竞争性更新，该研究评价了美沙酮与丁丙诺啡以及社区强化方法（CRA）联合和不联合应急管理（CM）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，CM的疗效有限，在代金券的价值降低到名义水平后，药物使用出现反弹。 在本研究和其他研究中确定的使用阿片类激动剂维持患者的CRA和CM的局限性包括患者解决可卡因使用问题的动机低;难以实施多方面和复杂的治疗;以及CM的疗效有限。 因此，我们提出了一项第一阶段研究，用于手动开发和试点测试基于行为和社会学习理论的治疗，用于阿片类药物和可卡因联合依赖的激动剂维持患者，解决CRA和CM在该人群中的几个弱点。 这种治疗被称为治疗性合同（TC），结合了社区强化方法（CRA）的核心方面，与当前研究中的改善结果以及基于认知和社会学习理论的技术相关，这些技术可以作为CM的替代方案，用于增强患者的动力，克服士气低落，并提高目标实现。 在拟议的研究中，我们计划首先完善TC，并制定一个单独的治疗手册和培训材料，它在10美沙酮维持阿片类药物和可卡因联合依赖患者的预试点测试。在试点前，我们还计划制定遵守技术合作和能力评级量表。 随后，我们计划进行一项试点研究，使用拆卸设计，比较TC和它的组成部分之一，手动指导的认知行为应对技能疗法（CBT）。 对于试点，3-5名治疗师将接受培训，以管理每种治疗，患者将被随机分配到24周的TC或CBT。 主要结果指标包括减少非法阿片类药物和可卡因的使用，并通过每周三次尿液毒理学测试和自我报告进行评估。 初步研究将用于估计这两种治疗之间差异的潜在效应量，并评价在更大规模的II期研究中比较TC和CBT的可行性。将通过评估治疗师是否能够接受培训以遵守手册并胜任治疗;患者是否能够继续接受治疗;以及对治疗分配设盲的评定者是否能够可靠地区分治疗来评价可行性。

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.