TY - JOUR
T1 - A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail
AU - Gordon, Michael S.
AU - Mitchell, Shannon Gwin
AU - Blue, Thomas R.
AU - Vocci, Frank J.
AU - Fishman, Marc J.
AU - Murphy, Sean M.
AU - Couvillion, Kathy
AU - Maher, Kelly
AU - Ryan, Danielle
AU - Wenzel, Kevin
AU - Danner, Martha L.
AU - Jarvis, Daniel K.
N1 - Funding Information:
Braeburn Pharmaceuticals is supplying free Brixadi (extended-release buprenorphine). Michael Gordon reports support (study drug) from Alkermes and research grant support from MedicaSafe. Frank Vocci reports consultation with Braeburn Pharmaceuticals, Lyndra Pharmaceuticals, and is Co-PI on a NIH grant with Nirsum Laboratories. Marc Fishman reports consultation and grant support from Alkermes, consultation with Drug Delivery LLX, Verily Life Sciences; and grant support from MedicaSafe. Sean Murphy reports having consulted for Sandoz Inc. The other authors report no conflicts.
Funding Information:
This work was supported by the National Institutes of Health and the National Institute on Drug Abuse [grant number 1UG1DA050077 ]; and Braeburn Pharmaceuticals, Inc.
Funding Information:
We thank the administration and staff at the participating Maryland county jails, health departments and community treatment programs. We would also like to thank all of the individual who will participate in this study. We would like to thank Jim Hedrick, Substance Use Disorder Policy Analyst from the Maryland Governor's Office of Crime Prevention, Youth, and Victim Services for his invaluable assistance and guidance with identifying county sites. We would also like to thank National Institute on Drug Abuse (NIDA) staff Tisha Wiley (Chief, Services Research Branch), Lori Ducharme (Health Scientist Administrator), and Carrie Mulford (Program Official). This work was supported by the National Institutes of Health and the National Institute on Drug Abuse [grant number 1UG1DA050077]; and Braeburn Pharmaceuticals, Inc.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2021/9
Y1 - 2021/9
N2 - This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.
AB - This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX. The proposed study is innovative because it will be the first randomized clinical trial in the U.S. assessing the effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, and re-incarceration. Understanding how to expand acceptance of medications for OUD in jails, particularly extended-release medications, and supporting treatment engagement and medication adherence in transition to the community, has far-reaching implications for improving treatment access and success in this population.
KW - Extended-release buprenorphine
KW - Extended-release naltrexone
KW - Jail
KW - Justice-involved
KW - Medications for opioid use disorders
UR - http://www.scopus.com/inward/record.url?scp=85097885505&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85097885505&partnerID=8YFLogxK
U2 - 10.1016/j.jsat.2020.108241
DO - 10.1016/j.jsat.2020.108241
M3 - Article
C2 - 33339633
AN - SCOPUS:85097885505
SN - 0740-5472
VL - 128
JO - Journal of Substance Abuse Treatment
JF - Journal of Substance Abuse Treatment
M1 - 108241
ER -