Optimizing Outcomes Using Suboxone for Opiate Dependence (R01 DA 020210-01)

描述（由申请人提供）： FDA批准丁丙诺啡（与纳洛酮结合作为Suboxone（r））使美国的医生能够在私人医疗环境中为阿片类药物依赖患者提供药物治疗。然而，丁丙诺啡被医生广泛接受和实施的速度比预期的要慢，这可能部分是由于为阿片类药物依赖患者提供综合治疗的性质和必要性。从美沙酮维持中吸取的教训清楚地表明，仅仅提供阿片类药物替代品并不能解决依赖的行为组成部分。虽然美国并不缺乏药物滥用的行为治疗设施，但缺乏的是使用药物治疗结合基于经验的行为治疗策略来治疗阿片类药物依赖的综合方法。该项目将评估三种特定行为策略的额外治疗效果，这些策略在基本医疗管理（med mgmt）平台的背景下提供，接近医生在开丁丙诺啡处方时通常会做的事情。240名参与者在两周稳定后将被随机分配到四组之一：（1）认知行为治疗（CBT/药物管理; n=60）强调预防复发，（2）应急管理（CM/med mgmt; n=60）提供连续无阿片类药物尿试验的激励，（3）包含CBT和CM的联合组（CBT+CM/药物管理; n=60），和（4）仅药物管理（既不CBT也不CM; n=60）。实验性行为疗法将与Suboxone（r）药物疗法联合使用16周（至研究第18周）。随后将使用Suboxone（r）进行额外16周的治疗（至研究第34周），在此期间不提供实验性行为疗法。所有参与者进入丁丙诺啡减量，并在研究第52周返回进行长期随访评价。试验的结果包括非法药物使用（在前18周内每周收集三次尿液药物样本），药物渴望，保留（方案中的天数），精神状态（抑郁，情绪），HIV风险行为和治疗可行性评级。结果将用于推荐策略，以优化丁丙诺啡治疗结果，并促进医生和治疗阿片类药物依赖患者的行为治疗机构整合药物治疗和心理社会/行为治疗策略。

DESCRIPTION (provided by applicant): The approval of buprenorphine (combined with naloxone as Suboxone(r)) by the FDA enables physicians in the United States to provide pharmacotherapy to opioid-dependent patients in private medical settings. Buprenorphine's wide acceptance and implementation by physicians has been slower than expected, however, and this may be due in part to the nature and necessity of providing comprehensive treatment for opioid-dependent patients. Lessons learned from methadone maintenance make it clear that simply providing opioid substitution does not address the behavioral components of dependence. While there is no lack of behavioral treatment facilities for substance abuse in the United States, what is lacking is an integrative approach to the treatment of opioid dependence using pharmacotherapy in conjunction with empirically based behavioral treatment strategies. This project will evaluate the added therapeutic effects of three specific behavioral strategies, delivered in the context of a basic medical management (med mgmt) platform approaching what physicians do, in general, when prescribing buprenorphine. Two-hundred forty (240) participants will be randomly assigned after a two week stabilization to one of four groups: (1) cognitive behavioral therapy (CBT/med mgmt; n=60) emphasizing relapse prevention, (2) contingency management (CM/med mgmt; n=60) providing incentives for successive opioid-free urine tests, (3) a combined group containing both CBT and CM (CBT+CM/med mgmt; n=60), and (4) med mgmt only (neither CBT nor CM; n=60). Experimental behavioral therapies will be delivered for 16 weeks (to study week 18) in conjunction with Suboxone(r) pharmacotherapy. An additional 16 weeks of treatment using Suboxone(r) (to study week 34) will ensue during which no experimental behavioral therapies are provided. All participants enter a buprenorphine taper and return at study week 52 for long-term follow-up evaluations. Outcomes for the trial include illicit drug use (urine drug samples collected three times per week during the first 18 weeks), drug craving, retention (days in the protocol), psychiatric status (depression, mood), HIV-risk behaviors, and treatment feasibility ratings. Results will be used to recommend strategies to optimize buprenorphine treatment outcomes and promote integration of pharmacotherapy and psychosocial/behavioral treatment strategies for physicians and for behavioral treatment facilities treating opioid-dependent patients.