Injectable pharmacotherapy for opioid use disorders (IPOD)
David Farabee, Maureen Hillhouse, Timothy Condon, Barbara McCrady, Kathryn McCollister, Walter Ling, David Farabee, Maureen Hillhouse, Timothy Condon, Barbara McCrady, Kathryn McCollister, Walter Ling
Abstract
Background: Despite the growing prevalence of opioid use among offenders, pharmacotherapy remains an underused treatment approach in correctional settings. The aim of this 4-year trial is to assess the clinical utility, effectiveness, and cost implications of extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc.) alone and in conjunction with patient navigation for jail inmates with opioid use disorder (OUD).
Methods: Opioid-dependent inmates will be randomly assigned to one of three treatment conditions before being released to the community to include: 1) XR-NTX only; 2) XR-NTX plus patient navigation (PN), and 3) enhanced treatment-as-usual (ETAU) with drug education and a community treatment referral. Before release from jail, participants in the XR-NTX and XR-NTX plus PN conditions will receive their first XR-NTX injection. Those in the XR-NTX plus PN condition also will meet with a patient navigator. Participants in both XR-NTX conditions will be scheduled for medical management sessions twice monthly for months 1-3, monthly medical management sessions for months 4-6, with monthly injections for 5months post-release (which, given the pre-release injection, results in a 6-month medication phase). Follow-up data collection will occur at 1, 3, 6, and 12months post release.
Results: We discuss the study's rationale, aims, methods, and anticipated findings. The primary outcome is the presence of a DSM 5 OUD diagnosis 1year after randomization (6months after the end of the active treatment phase).
Discussion: We hypothesize that providing XR-NTX prior to release from jail will be particularly beneficial for this extremely high-risk population by reducing opioid use, associated criminal behavior, and injection-related disease risk. ClinicalTrials.Gov: NCT02110264.
Keywords: Experimental; Extended release naltrexone; Injectable naltrexone; Jail inmates; Opioid dependence.
Conflict of interest statement
5. Conflicts of Interest
Drs. Farabee and Ling have received in-kind support in the form of study medications from Alkermes. Dr. McCrady has no conflicts of interest. Dr. Condon has received in-kind support in the form of study medication from Alkermes.
Copyright © 2016 Elsevier Inc. All rights reserved.
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Source: PubMed