Intensive Motivational Interviewing for Methamphetamine Dependence

描述（由申请人提供）：第2阶段随机临床试验（RCT）拟用于测试一种有前途的9期动机访谈（MI）模型对甲基苯丙胺（MA）依赖的疗效。第一阶段试点测试表明，干预措施可以很容易地学习和实施的保真度。30个MA依赖者的样本在9周内显示出MA使用的大幅减少，良好的保留和一致的出勤。量身定制的治疗方法借鉴了我们以前关于MI的概念性论文以及我们在各种MI方案方面的经验，包括两项MI临床试验网络（CTN）研究。“高剂量动机增强疗法”手册的一个创新特点是，它全面解决了已经实现持续清醒的客户以及仍在使用药物的客户的问题。因此，其目的是促进治疗的进入和参与，以及维持在治疗方面取得的成果。我们认为，一个更密集的MI模型是必要的，以解决MA依赖的个人，因为他们经常出现更严重的问题比其他物质依赖的个人，更容易失去他们在治疗中取得的成果。MA依赖型患者（N=220）将从加州拉斐特的New Leaf门诊治疗中招募。该研究中心开展研究的历史悠久，包括参与评估MA依赖治疗结局的多中心研究。研究参与者将被随机分配到1）单次动机访谈（MI）加8小时的健康/营养教育，或2）密集的9次MI干预。除了研究干预外，两组患者还将在New Leaf接受标准门诊治疗服务。在治疗的前9周内，将每周评估受试者是否使用MA。将在治疗入组以及2个月、4个月和6个月随访时进行更广泛的评估。两名治疗师将被“交叉”，并在两种情况下治疗客户。主要结局指标为MA使用的时间轴随访（TLFB）、MA尿分析结果和治疗保留率。次要结局将包括酒精和其他药物的ASI和TLFB。探索性分析将检查艾滋病毒的风险行为，动机和服务利用。调解模型将建立在Moyers等人（2005）的MI研究和我们的“支持性对抗”（Polcin等人，2006年）通过测试是否反馈加强了关于MA使用的潜在危害的警告，促进了治疗联盟，以及这是否反过来促进了更好的结果。最近的荟萃分析强调了该研究的重要性，该分析发现较高剂量的MI与较好的结果相关（Burke等人，2003年）。相反，最近几项针对药物依赖患者的标准单次MI研究对其有效性提出了质疑。MA依赖的客户是一个更密集的MI剂量的良好候选人，因为他们严重的医疗和心理问题。因此，现在是时候测试这个有前途的干预作为一个有用的扩展标准MI的客户与MA依赖。 公共卫生相关性：该提案是对国家药物滥用计划公告研究所“行为和综合治疗发展计划”（PA-07-111）的回应。该研究测试了一种新的9节“动机访谈”咨询手册是否比最常用的标准单节更有效地治疗甲基苯丙胺依赖。寻找有效的治疗甲基苯丙胺依赖是重要的，因为甲基苯丙胺的使用正在迅速增加，在某些地区，如美国西部，正在达到流行病的比例。

DESCRIPTION (provided by applicant): A Stage 2 randomized clinical trial (RCT) is proposed to test the efficacy of a promising 9-session model of motivational interviewing (MI) for methamphetamine (MA) dependence. Stage 1 pilot testing indicated the intervention could be easily learned and implemented with fidelity. The sample of 30 MA dependent individuals over 9 weeks showed large reductions in MA use, good retention and consistent attendance. The tailored treatment approach draws upon our previous conceptual papers on MI as well as our experience with a variety of MI protocols, including two Clinical Trials Network (CTN) studies of MI. An innovative feature of the "Higher Dose Motivational Enhancement Therapy" manual is that it comprehensively addresses the issues of clients who have achieved sustained sobriety as well as those still using substances. Thus, it is designed to facilitate treatment entry and engagement as well as maintenance of the gains made in treatment. We posit that a more intensive MI model is necessary to address MA dependent individuals because they frequently present more serious problems than individuals with other substance dependencies and are more prone to lose the gains they make in treatment. MA dependent clients (N=220) will be recruited from New Leaf outpatient treatment in Lafayette, California. This site has a long history of conducting research, including participation in a multi-site study assessing treatment outcome of MA dependence. Study participants will be randomly assigned to 1) a single session of Motivational Interviewing (MI) plus 8 hours of health/nutrition education, or 2) the intensive 9-session MI intervention. In addition to the study interventions, both groups will receive standard outpatient treatment services at New Leaf. Participants will be assessed weekly during the first 9 weeks of treatment for MA use. More extensive assessments will be conducted at treatment entry and 2-, 4-and 6-month follow-ups. Two therapists will be "crossed" and treat clients in both conditions. Primary outcome measures will be the Timeline Follow Back (TLFB) for MA use, MA urinalysis results, and retention in treatment. Secondary outcomes will include the ASI and the TLFB for alcohol and other drugs. Exploratory analyses will examine HIV risk behaviors, motivation, and service utilization. A mediation model will build upon MI research by Moyers et al. (2005) and our construct of "supportive confrontation" (Polcin, et al., 2006) by testing whether feedback enhanced with warnings about the potential harm of MA use facilitates the therapeutic alliance, and whether this in turn facilitates better outcome. The significance of the study is highlighted by a recent meta-analysis finding higher doses of MI were associated with better outcomes (Burke et al., 2003). Conversely, several recent studies of standard single session MI with drug dependent clients questioned its effectiveness. Clients with MA dependence are good candidates for a more intensive dose of MI because of their severe medical and psychosocial problems. Thus, it is time to test this promising intervention as a useful extension of standard MI for clients with MA dependence. PUBLIC HEALTH RELEVANCE: This proposal responds to the National Institute on Drug Abuse Program Announcement, "Behavioral & Integrative Treatment Development Program" (PA-07-111). The study tests whether a new 9- session manual of "Motivational Interviewing" counseling is more effective for treating methamphetamine dependence than the standard single session that is used most commonly. Finding effective treatments for methamphetamine dependence is important because methamphetamine use is rapidly increasing and in some areas, such as the Western U.S, is reaching epidemic proportions.