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: 8607917
• 负责人: ROBERT P SCHWARTZ
• 金额: $ 42.11万
• 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 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8607917
• 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 Infections; HIV risk; 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; public health relevance; 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.

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。

项目成果

When does methadone treatment reduce arrest and severity of arrest charges? An analysis of arrest records.

美沙酮治疗何时可以减少逮捕和逮捕指控的严重程度？

• DOI: 10.1016/j.drugalcdep.2017.08.025
• 发表时间: 2017
• 期刊: Drug and alcohol dependence
• 影响因子: 4.2
• 作者: Schwartz,RobertP;Kelly,SharonM;Mitchell,ShannonGwinn;Gryczynski,Jan;O'Grady,KevinE;Jaffe,JeromeH
• 通讯作者: Jaffe,JeromeH

Predictors of methadone treatment retention from a multi-site study: a survival analysis.

• DOI: 10.1016/j.drugalcdep.2011.01.008
• 发表时间: 2011-09-01
• 期刊: DRUG AND ALCOHOL DEPENDENCE
• 影响因子: 4.2
• 作者: Kelly, Sharon M.;O'Grady, Kevin E.;Mitchell, Shannon Gwin;Brown, Barry S.;Schwartz, Robert P.
• 通讯作者: Schwartz, Robert P.

Heroin Use, HIV-Risk, and Criminal Behavior in Baltimore: Findings from Clinical Research.

• DOI: 10.1080/10550887.2015.1059222
• 发表时间: 2015
• 期刊: Journal of addictive diseases
• 影响因子: 2.3
• 作者: Schwartz RP;Kelly SM;Gryczynski J;Mitchell SG;O'Grady KE;Jaffe JH
• 通讯作者: Jaffe JH

Initiating methadone in jail and in the community: Patient differences and implications of methadone treatment for reducing arrests.

在监狱和社区开始使用美沙酮：患者差异以及美沙酮治疗对减少逮捕的影响。

• DOI: 10.1016/j.jsat.2018.11.006
• 发表时间: 2019
• 期刊: Journal of substance abuse treatment
• 影响因子: 3.9
• 作者: Schwartz,RobertP;Kelly,SharonM;Mitchell,ShannonGwin;Gryczynski,Jan;O'Grady,KevinE;Jaffe,JeromeH
• 通讯作者: Jaffe,JeromeH

Incarceration and opioid withdrawal: the experiences of methadone patients and out-of-treatment heroin users.

• DOI: 10.1080/02791072.2009.10399907
• 发表时间: 2009-06
• 期刊: Journal of psychoactive drugs
• 影响因子: 2.8
• 作者: Mitchell SG;Kelly SM;Brown BS;Reisinger HS;Peterson JA;Ruhf A;Agar MH;Schwartz RP
• 通讯作者: Schwartz RP