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

使用 Suboxone 治疗阿片类药物依赖性优化结果 (R01 DA 020210-01)

• 批准号: 7097067
• 负责人: WALTER NMN LING
• 金额: $ 51.77万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7097067
• 关键词: buprenorphine; chemotherapy; clinical research; physicians

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.

描述（由申请人提供）： 丁丙诺啡（与纳洛酮作为亚智酮（R）结合使用，FDA可以使美国医生在私人医疗环境中为阿片类药物依赖性患者提供药物治疗。但是，丁丙诺啡对医生的广泛接受和实施的速度比预期的要慢，这可能部分归因于为阿片类药物依赖性患者提供全面治疗的性质和必要性。从美沙酮维护中学到的经验教训清楚地表明，仅提供阿片类药物替代并不能解决依赖的行为组成部分。尽管在美国不缺乏滥用药物滥用的行为治疗设施，但缺乏的是一种使用药物治疗以及基于经验的行为治疗策略来治疗阿片类药物依赖性的综合方法。该项目将评估在基本医疗管理（MED MGMT）平台上提供的三种特定行为策略的额外治疗效果，从而在开处方丁丙诺啡时接近医生的工作。 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）和（4）MED MGMT（均不CBT和CM; n = 60）。实验行为疗法将与亚毒素（R）药物疗法结合使用16周（学习第18周）。随后将使用Suboxone（R）（进行第34周）进行另外16周的治疗，在此期间未提供实验性行为疗法。所有参与者都进入丁丙诺啡锥度，并在第52周进行回报进行长期随访评估。该试验的结果包括非法药物使用（在头18周内每周收集3次尿液药物样本），渴望药物，保留率（协议的天数），精神病状态（抑郁，情绪），HIV风险行为和治疗可行性评级。结果将用于推荐优化丁丙诺啡治疗结果的策略，并促进医生的药物治疗和心理社会/行为治疗策略的整合，并为治疗阿片类药物依赖性患者的行为治疗设施提供。