TY - JOUR
T1 - Injectable pharmacotherapy for opioid use disorders (IPOD)
AU - Farabee, David
AU - Hillhouse, Maureen
AU - Condon, Timothy
AU - McCrady, Barbara
AU - McCollister, Kathryn
AU - Ling, Walter
N1 - Funding Information:
Funding for this study is provided by NIDA through a cooperative agreement ( U01DA034743 ; PI: David Farabee, PI). The other collaborating sites under this cooperative are New York University ( U01DA033336 ; PI: Josh Lee) and Friends Research Inc. , ( U01DA013636 ; PI: Robert Schwartz). The NIDA Science Partner is Redonna Chandler.
PY - 2016/7/1
Y1 - 2016/7/1
N2 - 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 5 months 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 12 months 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 1 year after randomization (6 months 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.
AB - 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 5 months 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 12 months 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 1 year after randomization (6 months 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.
KW - Experimental
KW - Extended release naltrexone
KW - Injectable naltrexone
KW - Jail inmates
KW - Opioid dependence
UR - http://www.scopus.com/inward/record.url?scp=84968762529&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84968762529&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2016.06.003
DO - 10.1016/j.cct.2016.06.003
M3 - Article
C2 - 27282118
AN - SCOPUS:84968762529
VL - 49
SP - 70
EP - 77
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
ER -