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（与纳洛酮组合为 Suboxone(r)），使美国医生能够在私人医疗机构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要慢，这可能部分归因于为阿片类药物依赖患者提供综合治疗的性质和必要性。美沙酮维持治疗的经验教训表明，仅仅提供阿片类药物替代并不能解决依赖性的行为问题。虽然美国不缺乏针对药物滥用的行为治疗设施，但缺乏的是使用药物疗法与基于经验的行为治疗策略相结合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附加治疗效果，这些策略是在基本医疗管理 (med mgmt) 平台的背景下提供的，该平台接近医生在开丁丙诺啡处方时的一般做法。两周稳定后，两百四十 (240) 名参与者将被随机分配到四组之一：(1) 认知行为疗法 (CBT/med mgmt；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液检测的激励，(3) 包含 CBT 和 CM 的组合组 (CBT CM/med mgmt；n=60) n=60)，以及(4)仅进行药物治疗（既不是CBT也不是CM；n=60）。实验性行为疗法将与 Suboxone(r) 药物疗法相结合，持续 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。所有参与者均进入丁丙诺啡减量阶段，并在研究第 52 周返回进行长期随访评估。试验结果包括非法药物使用（前 18 周内每周收集 3 次尿液药物样本）、药物渴望、保留时间（方案中的天数）、精神状况（抑郁、情绪）、艾滋病毒风险行为和治疗可行性评级。结果将用于推荐优化丁丙诺啡治疗结果的策略，并促进医生和治疗阿片类药物依赖患者的行为治疗机构的药物治疗和心理社会/行为治疗策略的整合。

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.