TY  - JOUR
PY  - 2020//
TI  - 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
JO  - Drug and alcohol dependence
A1  - Mitchell, Mary M.
A1  - Schwartz, Robert P.
A1  - Choo, Tse-Hwei
A1  - Pavlicova, Martina
A1  - O'Grady, Kevin E.
A1  - Gryczynski, Jan
A1  - Stitzer, Maxine L.
A1  - Nunes, Edward V.
A1  - Rotrosen, John
SP  - e108422
EP  - e108422
VL  - 219
IS  - 
N2  - 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>
LA  - en
SN  - 0376-8716
UR  - http://dx.doi.org/10.1016/j.drugalcdep.2020.108422
ID  - ref1
ER  -