Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: Rationale and design of a randomized controlled effectiveness trial
In: Contemporary Clinical Trials, Jg. 41 (2015-03-01), S. 110-117
Online
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Background 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. Methods 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. Results We describe the rationale, specific aims, and design of the study. Alternative design considerations and extensive secondary aims and outcomes are discussed. Conclusions XR-NTX is a potentially important treatment and relapse prevention option among persons with opioid dependence and CJS involvement. ClinicalTrials.gov: NCT00781898 Language: en
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Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: Rationale and design of a randomized controlled effectiveness trial
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Autor/in / Beteiligte Person: | Fishman, Marc ; McDonald, Ryan ; Cornish, James W. ; Chen, Donna T. ; O'Brien, Charles P. ; Nunes, Edward V. ; Hoskinson, Randall ; Friedmann, Peter D. ; Bonnie, Richard J. ; Boney, Tamara Y. ; Gordon, Michael S. ; Kinlock, Timothy W. ; Lee, Joshua D. |
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Zeitschrift: | Contemporary Clinical Trials, Jg. 41 (2015-03-01), S. 110-117 |
Veröffentlichung: | Elsevier BV, 2015 |
Medientyp: | unknown |
ISSN: | 1551-7144 (print) |
DOI: | 10.1016/j.cct.2015.01.005 |
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