Re-engineering Methadone Treatment: A Randomized Clinical Trial

重新设计美沙酮治疗：随机临床试验

• 批准号: 8129970
• 负责人: ROBERT P SCHWARTZ
• 金额: $ 66.59万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-01 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8129970
• 关键词: Abstinence; Accreditation; Admission activity; Agonist; Body Weight decreased; Caring; Categories; Chronic; Chronic Disease; Client satisfaction; Clinic; Cocaine Dependence; Conflict (Psychology); Costs and Benefits; Counseling; Crime; DSM-IV; Dependence; Diet; Drops; Drug Addiction; Drug abuse; Drug usage; Economics; Engineering; Enrollment; Environment; Fees; Goals; Gold; HIV; HIV Infections; Heroin; Heroin Dependence; Illicit Drugs; Imprisonment; Indium; Insulin; Interview; Lead; Measures; Medical; Medicine; Methadone; Modality; Modeling; Opiate Addiction; Opioid; Outcome; Outcome Measure; Overdose; Parents; Participant; Patient Discharge; Patient-Centered Care; Patients; Pharmaceutical Preparations; Policy Maker; Primary Health Care; Procedures; Professional counselor; Public Health; Quality of life; Randomized Clinical Trials; Recommendation; Regulation; Relative (related person); Research; Risk Behaviors; Role; Safety; Sampling; Services; Site; Structure; Testing; Therapeutic; Thinking; Time; Treatment outcome; Urine; active method; base; clinical practice; cocaine use; comparative; cost; cost effectiveness; criminal behavior; drug quality; effective therapy; flexibility; follow-up; improved; innovation; meetings; non-compliance; novel; novel strategies; outcome forecast; outreach; overdose death; parent grant; patient oriented; premature; prevent; programs; response; treatment as usual; treatment program

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.

描述（由申请人提供）：过早停止美沙酮治疗计划（MTP）是一种常见的情况，并与持续非法药物使用，艾滋病毒感染，过量死亡和犯罪有关。我们的竞争性续期申请的重新提交建立在我们的父母补助金（5 R 01 DA 015842）的调查结果的基础上，其中350多名新入院的MTP中有近一半在12个月随访时不再接受治疗，这在很大程度上是因为程序规则的强大影响力和辅导员作为规则执行者的作用。我们的目标是基于以患者为中心的护理的概念模型（IOM，2006）1，测试MTP的基本重新设计的影响，以避免过早脱落并改善患者的结局。在我们的母公司R 01中，几乎所有的提前出院都是由于：（1）“行政”出院，通常是非自愿的;（2）患者辍学;或（3）短暂监禁后未再次入院。为了减少“行政”解雇，PC-MTP将重新组织工作人员的作用和MTP规则。咨询师将不负责为病人执行诊所的规则，病人将被鼓励但不被要求参加咨询，大多数违反诊所规则的行为将导致“行政”出院的后果。行政出院，在医学上找不到其他地方，尽管在MTP中很常见，与阿片类药物成瘾作为一种慢性疾病的概念不一致。解除咨询师的强制者角色，使咨询自愿，应减轻内在的冲突和权力的不平衡，从而增加治疗联盟和病人的满意度，从而治疗保留。最后，MTP将积极欢迎患者在释放后返回治疗，而没有任意的返回期限，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名参与者的双中心随机临床试验将在意向治疗的基础上比较PC-MTP与常规治疗MTP（TAU）的相对疗效。将在基线和基线后3、6和12个月对受试者进行评估。这项研究的目的是：（1）比较PC-MTP与TAU对以下方面的影响：a）治疗天数; B）海洛因和可卡因使用; c）HIV风险行为; d）犯罪行为和逮捕; e）生活质量; f）12个月随访时符合DSM-IV海洛因和可卡因依赖标准的可能性;（2）治疗联合和患者满意度;（3）成本、成本效益和成本效益。这项研究有望审查在过去40年中基本保持不变的中期计划结构的重新设计。此外，由于某些药物的使用并不等同于依赖，因此我们纳入了生活质量和DSM-IV药物依赖的措施，因此，我们的研究结果可能会挑战长期持有的黄金标准，即认为完全禁欲是患者进展的最重要指标。由于MTP过早出院的预后不良，增加治疗保留可能对患者的总体结局、公共卫生和治疗的成本效益产生强大影响。 公共卫生关系：这项拟议的研究是重要的，因为新入院的美沙酮治疗患者在治疗的第一年有很高的过早出院率。过早从美沙酮治疗中出院与吸毒、过量、艾滋病毒风险和犯罪行为有关。这项拟议的研究是创新的，因为它试图测试一个新的变化，以通常的美沙酮治疗计划的结构，已仅略有变化，自20世纪70年代初。拟议研究的公共卫生影响将很大，因为该研究可能揭示，与常规治疗相比，这种新的治疗方法可以预防非法药物使用，艾滋病毒风险行为，犯罪和过量。