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Re-engineering Methadone Treatment: A Randomized Clinical Trial

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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.
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