TY  - JOUR
PY  - 2015//
TI  - Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial
JO  - Contemporary clinical trials
A1  - Lee, Joshua D.
A1  - Friedmann, Peter D.
A1  - Boney, Tamara Y.
A1  - Hoskinson Jr., Randall A.
A1  - McDonald, Ryan
A1  - Gordon, Michael
A1  - Fishman, Marc
A1  - Chen, Donna T.
A1  - Bonnie, Richard J.
A1  - Kinlock, Timothy W.
A1  - Nunes, Edward V.
A1  - Cornish, James W.
A1  - O'Brien, Charles P.
SP  - 110
EP  - 117
VL  - 41
IS  - 
N2  - 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<p />  <p>Language: en</p>
LA  - en
SN  - 1551-7144
UR  - http://dx.doi.org/10.1016/j.cct.2015.01.005
ID  - ref1
ER  -