@article{ref1,
title="An alternative analysis of illicit opioid use during treatment in a randomized trial of extended-release naltrexone versus buprenorphine-naloxone: a per-protocol and completers analysis",
journal="Drug and alcohol dependence",
year="2020",
author="Mitchell, Mary M. and Schwartz, Robert P. and Choo, Tse-Hwei and Pavlicova, Martina and O'Grady, Kevin E. and Gryczynski, Jan and Stitzer, Maxine L. and Nunes, Edward V. and Rotrosen, John",
volume="219",
number="",
pages="e108422-e108422",
abstract="BACKGROUND: The distinct pharmacological properties and clinical uses of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) present challenges in analyzing patient outcomes.   METHODS: We conducted a secondary analysis of a multi-site randomized trial comparing XR-NTX with sublingual BUP-NX treatment for opioid use disorder initiated during inpatient detoxification and continued in outpatient treatment. Urine testing data for non-study opioids from the last 22 weeks of the 24-week trial were analyzed in both a per-protocol sample (n = 474 participants who received at least one dose of medication) and a completers sample (n = 211 participants who received all XR-NTX doses or all BUP-NX prescriptions). The present analyses sought to identify differences in the weekly percentages of opioid-positive urine tests between participants treated with the two medications.   RESULTS: The proportion of opioid-positive tests in both conditions was less than 20 % for 21 of the 22 weeks in the per-protocol sample and all 22 weeks in the completers sample. Generalized linear mixed model analyses revealed a significant treatment (XR-NTX vs. BUP-NX) X week (weeks 3-24) interaction in the per-protocol sample but not the completers sample. In the per-protocol analysis, the BUP-NX, compared to XR-NTX, had significantly greater proportions of opioid-positive tests in 14 out of the 22 weeks.   CONCLUSIONS: Longitudinal modeling approaches that utilize flexible procedures for handling missing data can offer a different perspective on study findings. <br><br>RESULTS from the present analyses suggest that XR-NTX appeared to be somewhat more effective than BUP-NX in reducing illicit opioid use in the per-protocol sample.<p /> <p>Language: en</p>",
language="en",
issn="0376-8716",
doi="10.1016/j.drugalcdep.2020.108422",
url="http://dx.doi.org/10.1016/j.drugalcdep.2020.108422"
}