Injectable pharmacotherapy for opioid use disorders (IPOD).
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).



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.



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).



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.
UCLA Integrated Substance Abuse Programs, Department of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles, United States. Electronic address: dfarabee@ucla.edu.
David
D
Farabee
UCLA Integrated Substance Abuse Programs, Department of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles, United States.
Maureen
M
Hillhouse
Center on Alcoholism, Substance Abuse, and Addictions, The University of New Mexico, United States.
Timothy
T
Condon
Center on Alcoholism, Substance Abuse, and Addictions, The University of New Mexico, United States.
Barbara
B
McCrady
Department of Public Health Sciences, University of Miami Miller School of Medicine, United States.
Kathryn
K
McCollister
UCLA Integrated Substance Abuse Programs, Department of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles, United States.
Walter
W
Ling
D003692:Delayed-Action Preparations; D006801:Humans; D007273:Injections, Intramuscular; D009271:Naltrexone / Q000008:administration & dosage*; D009292:Narcotic Antagonists / Q000008:administration & dosage*; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000534:rehabilitation; D062526:Patient Navigation / Q000379:methods*; D011329:Prisoners; D011330:Prisons
D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
Experimental; Extended release naltrexone; Injectable naltrexone; Jail inmates; Opioid dependence