Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: A Pilot Randomized Controlled Trial

PROJECT SUMMARY
This K23 application proposes novel research in opioid use disorder (OUD) treatment in a correctional
healthcare setting and a robust training plan to support the successful transition of the Dr. Justin Berk, MD
MPH MBA (PI) to independent clinician-scientist. His background in public health, health management, and
clinical medicine creates a strong foundation for further development as an expert scientist. He has assembled
a highly accomplished and diverse team of nationally recognized mentors and advisors with complementary
expertise in clinical trials and other research among vulnerable populations including qualitative methodologies
and implementation science. The proposed research work will provide hands-on experience instrumental to Dr.
Berk’s career progression as a clinical trialist preliminary data for a future multi-site R01 application. The
Rhode Island Department of Corrections (RIDOC) is an ideal setting for this type of pilot study.
Medications for opioid use disorder (MOUD) are an effective treatment in the community and among
incarcerated individuals. Given the high prevalence OUD in jails and prisons and the high risk of opioid
overdose upon release, the criminal justice (CJ) system offers a targeted opportunity to engage individuals in
treatment initiation. Despite the strong evidence-base for MOUD, few correctional facilities offer these life-
saving medications. A shifting policy landscape in legislation and court rulings will lead to more facilities
offering MOUD treatment. Delivery barriers, however, still exist. A new injectable extended-release form of
buprenorphine (XR-B) can help overcome these barriers, though there is no published literature on its
effectiveness or implementation in a CJ setting. This K23 proposes a randomized controlled trial (RCT) to
demonstrate preliminary effectiveness, acceptability, and feasibility of XR-B and uses a concomitant process
evaluation, with frameworks frequently used in implementation science, to investigate how this novel treatment
modality may be used in a CJ setting to prevent opioid overdose in the high-risk time of re-entry to the
community.
The specific aims of this K23 proposal include: (Aim 1) Compare XR-B initiation to treatment-as-usual
sublingual buprenorphine among incarcerated individuals on treatment engagement, re-incarceration,
overdose, buprenorphine adherence, and illicit opioid use. (Aim 2) Conduct a process evaluation using the RE-
AIM evaluative framework and iPARIHS implementation science framework to assess the implementation of
XR-B initiation and identify facilitators to and barriers of MOUD treatment in a CJ setting.
In order to achieve these aims and move towards research independence, Dr. Berk will receive training
and experience in clinical trial research, including supporting qualitative methodologies and implementation
science, and build a career to conduct high-impact and ethical research in a marginalized population.

Grant Number: 5K23DA055695-04
NIH Institute/Center: NIH
Principal Investigator: Justin Berk