@article{ref1,
title="Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: a phase 3 randomized trial",
journal="Drug and alcohol dependence",
year="2018",
author="Bisaga, Adam and Mannelli, Paolo and Yu, Miao and Nangia, Narinder and Graham, Christine E. and Tompkins, D. Andrew and Kosten, Thomas R. and Akerman, Sarah C. and Silverman, Bernard L. and Sullivan, Maria A.",
volume="187",
number="",
pages="171-178",
abstract="BACKGROUND: Injectable extended-release naltrexone (XR-NTX), approved to prevent relapse to opioid dependence, requires initial abstinence. This multisite outpatient clinical trial examined the efficacy and safety of low-dose oral naltrexone (NTX), combined with a brief buprenorphine (BUP) taper and standing ancillary medications, for detoxification and induction onto XR-NTX. <br><br>METHODS: Patients (N = 378) were randomized, stratified by primary short-acting opioid-of-use, to one of three regimens: NTX + BUP; NTX + placebo BUP (PBO-B); placebo NTX (PBO-N) + PBO-B. Patients received 7 days of ascending NTX or placebo, concurrent with a 3-day BUP or placebo taper, and ancillary medications in an outpatient setting. Daily psychoeducational counseling was provided. On Day 8, patients passing a naloxone challenge received XR-NTX. <br><br>RESULTS: Rates of transition to XR-NTX were comparable across groups: NTX/BUP (46.0%) vs. NTX/PBO-B (40.5%) vs. PBO-N/PBO-B (46.0%). Thus, the study did not meet its primary endpoint. Adverse events, reported by 32.5% of all patients, were mild to moderate in severity and consistent with opioid withdrawal. A first, second, and third XR-NTX injection was received by 44.4%, 29.9%, and 22.5% of patients, respectively. Compared with the PBO-N/PBO-B group, the NTX/BUP group demonstrated higher opioid abstinence during the transition and lower post-XR-NTX subjective opioid withdrawal scores. <br><br>CONCLUSIONS: A 7-day detoxification protocol with NTX alone or NTX + BUP provided similar rates of induction to XR-NTX as placebo. For those inducted onto XR-NTX, management of opioid withdrawal symptoms prior to induction was achieved in a structured outpatient setting using a well-tolerated, fixed-dose ancillary medication regimen common to all three groups.<br><br>Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.<p /> <p>Language: en</p>",
language="en",
issn="0376-8716",
doi="10.1016/j.drugalcdep.2018.02.023",
url="http://dx.doi.org/10.1016/j.drugalcdep.2018.02.023"
}