Optimizing Outcomes Using Suboxone for Opiate Dependence

描述(由申请人提供)： FDA批准丁丙诺啡(与纳洛酮联合作为Suboxone(R))，使美国的医生能够在私人医疗环境中为阿片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慢于预期，部分原因可能是为阿片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，简单地提供阿片类药物替代并不能解决依赖的行为成分。虽然美国不乏针对药物滥用的行为治疗设施，但缺乏的是将药物治疗与基于经验的行为治疗策略结合使用来治疗阿片依赖的综合方法。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时通常会做的事情。240名受试者在两周稳定下来后将被随机分配到四组中的一组：(1)强调预防复发的认知行为疗法(CBT/MED MGMT；n=60)，(2)应急管理(CM/MED MGMT；n=60)，为连续的无阿片类药物尿检提供激励，(3)同时包含CBT和CM的联合组(CBT/MED MGMT；n=60)，以及(4)仅MED MGMT(既不包括CBT，也不包括CM；n=60)。试验性行为疗法将在Suboxone(R)药物疗法的同时进行16周(学习第18周)。接下来将再用Suboxone(R)进行16周的治疗(研究第34周)，在此期间不提供实验性的行为疗法。所有参与者都进入丁丙诺啡减量试验，并在第52周返回进行长期随访评估。试验的结果包括非法药物使用(前18周每周收集三次尿药样本)、对药物的渴望、滞留(协议中的天数)、精神状态(抑郁、情绪)、艾滋病毒危险行为和治疗可行性评级。结果将被用来建议优化丁丙诺啡治疗结果的战略，并促进药物治疗与心理/行为治疗战略的整合，用于医生和治疗阿片类药物依赖患者的行为治疗设施。

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.