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- W2003035491 abstract "Extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. This 5-site open-label randomized controlled effectiveness trial examines whether XR-NTX reduces opioid relapse compared with treatment as usual (TAU) among community dwelling, non-incarcerated volunteers with current or recent CJS involvement. The XR-NTX arm receives 6 monthly XR-NTX injections at Medical Management visits; the TAU group receives referrals to available community treatment options. Assessments occur every 2 weeks during a 24-week treatment phase and at 12- and 18-month follow-ups. The primary outcome is a relapse event, defined as either self-report or urine toxicology evidence of ≥ 10 days of opioid use in a 28-day (4 week) period, with a positive or missing urine test counted as 5 days of opioid use. We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed. XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898" @default.
- W2003035491 created "2016-06-24" @default.
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- W2003035491 date "2015-03-01" @default.
- W2003035491 modified "2023-10-18" @default.
- W2003035491 title "Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: Rationale and design of a randomized controlled effectiveness trial" @default.
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- W2003035491 doi "https://doi.org/10.1016/j.cct.2015.01.005" @default.
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