Re-engineering Methadone Treatment: A Randomized Clinical Trial

描述(由申请人提供)：过早停止美沙酮治疗计划(MTP)是一种经常发生的现象，与持续的非法药物使用、艾滋病毒感染、过量死亡和犯罪有关。我们的竞争续签申请的重新提交建立在我们的父母补助金(5R01DA 015842)的结果之上，在该结果中，350多名新入院的MTP中有近一半在12个月的随访中不再接受治疗，这在很大程度上是因为计划规则的强大影响力以及辅导员作为规则的执行者的角色。我们的目标是根据以患者为中心的护理概念模型(IOM，2006)，1测试对MTP进行根本性重新设计的影响，以避免过早辍学并改善患者结果。我们的父母R01中几乎所有的过早出院都是由于：(1)“行政”出院，通常是非自愿的；(2)病人辍学；或(3)短暂监禁后没有重新入院。为了减少“行政”解雇，PC-MTP将重新组织工作人员的角色和MTP规则。咨询师将不负责为他们的患者执行诊所的规则，患者将被鼓励但不被要求参与咨询，而且大多数违反诊所规则的行为将导致不会产生“行政”出院的后果。尽管在MTP中很常见，但在医学上找不到其他地方的行政放电，这与阿片成瘾是一种慢性病的概念不一致。解除咨询师的执行者角色，使咨询自愿，应缓解固有的冲突和权力失衡，从而增加治疗联盟和患者满意度，从而提高治疗保留率。最后，MTP将积极欢迎患者在出院后返回治疗，而不会武断地设定返回的最后期限，他们的顾问将为没有自行返回的参与者进行积极的外展。这项有300名参与者参加的两点随机临床试验将在意向治疗的基础上比较PC-MTP和常规治疗MTP(TAU)的相对疗效。参与者将在基线以及基线后3个月、6个月和12个月进行评估。这项研究的目的是：(1)比较PC-MTP和TAU在以下方面的影响：a)治疗天数；b)海洛因和可卡因的使用；c)艾滋病毒危险行为；d)犯罪行为和逮捕；e)生活质量；f)在12个月的随访中达到DSM-IV海洛因和可卡因依赖标准的可能性；(2)治疗联盟和患者满意度；以及(3)成本、成本效益和成本效益。这项研究承诺对过去40年来基本保持不变的MTP结构进行重新设计。此外，由于一些药物使用并不等同于依赖，我们将生活质量和DSM-IV药物依赖的测量纳入其中，因此，我们的发现可能会挑战长期持有的黄金标准，即认为完全戒酒是衡量患者进展的最重要指标。由于MTP患者过早出院的预后较差，增加治疗留存率对患者的整体预后、公众健康和治疗成本效益都有很大影响。 公共卫生相关性：这项拟议的研究意义重大，因为新入院的美沙酮治疗患者在治疗的第一年有很高的提前排泄率。美沙酮治疗的过早排出与药物使用、过量用药、艾滋病毒风险和犯罪行为有关。这项拟议的研究具有创新性，因为它试图测试对通常的美沙酮治疗方案结构的新改变，自20世纪70年代初以来，这种结构只做了轻微的改变。这项拟议的研究对公众健康的影响将是很高的，因为该研究可能会揭示，与通常的治疗相比，这种新的治疗方法可以防止非法药物使用、艾滋病毒危险行为、犯罪和过量服药。

DESCRIPTION (provided by applicant): Premature discontinuation from methadone treatment programs (MTP) is a frequent occurrence and is associated with continued illicit drug use, HIV infection, overdose death, and crime. This resubmission of our competing renewal application builds on the findings of our parent grant (5R01DA 015842) in which nearly half of over 350 newly admitted MTP were no longer in treatment at 12-month follow-up, in large part because of the powerful influence of program rules and the role of the counselor as enforcer of the rules. Our goal is to test the impact of a fundamental re-engineering of MTPs, based on the conceptual model of patient-centered care (IOM, 2006),1 in order to avoid premature drop-out and to improve patient outcomes. Nearly all premature discharges in our parent R01 were due to: (1) "administrative" discharge, typically involuntary; (2) patient drop-out; or, (3) not being re-admitted after brief incarcerations. To reduce "administrative" discharge, PC-MTP will reorganize the staff roles and MTP rules. Counselors will not be responsible for enforcing the clinics' rules for their patients, patients will be encouraged but not required to participate in counseling, and most clinic rule infractions will result in consequences short of "administrative" discharge. Administrative discharge, found nowhere else in medicine although common among MTPs, is incongruent with the conceptualization of opioid addiction as a chronic disease. Relieving the counselor of the role of enforcer and making counseling voluntary should alleviate the inherent conflict and power imbalance thereby increasing the therapeutic alliance and patient satisfaction and hence treatment retention. Finally, patients will be actively welcomed by the MTP to return to treatment upon release without arbitrary deadlines to return and their counselors will conduct active outreach for participants not returning on their own. This two-site randomized clinical trial with 300 participants will compare, on an intent-to-treat basis, the relative efficacy of PC-MTP to treatment-as-usual MTP (TAU). Participants will be assessed at baseline and at 3, 6 and 12 months post-baseline. The study's aims are: (1) to compare the impact of PC-MTP to TAU on: a) days in treatment; b) heroin and cocaine use; c) HIV risk behavior; d) criminal behavior and arrest; e) quality of life; and f) likelihood of meeting DSM-IV criteria for heroin and cocaine dependence at 12 month follow-up; (2) on therapeutic alliance and patient satisfaction; and (3) cost, cost-effectiveness, and cost-benefit. This study promises to examine the re-engineering of an MTP structure that has largely remained unchanged for the past 40 years. Further, since some drug use is not tantamount to dependence, we are including measures of quality of life and DSM-IV drug dependence and hence, our findings may challenge the long held gold standard that considers complete abstinence as the most important measure of patient progress. Because of the poor prognosis of premature discharge in MTPs, increasing retention in treatment can have a powerful effect on overall patient outcome, public health and on cost-benefit of treatment. PUBLIC HEALTH RELEVANCE: The proposed study is significant because newly-admitted methadone treatment patients have a high premature discharge rate during the first year of treatment. Premature discharge from methadone treatment is associated with drug use, overdose, HIV risk and criminal behavior. The proposed study is innovative because it seeks to test a novel change to the usual methadone treatment program structures which have been only modestly changed since the early 1970s. The public health impact of the proposed study will be high because the study may reveal that this new approach to treatment can prevent illicit drug use, HIV risk behavior, crime and overdose as compared to treatment as usual.