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

Award Number: K23DA055695
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 06/01/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $195,696 )
2026	2026	RHODE ISLAND HOSPITAL	593 EDDY ST	PROVIDENCE	RI	02903	PROVIDENCE	USA	Drug Use and Addiction Research Programs	000	5	6/3/2026	NON-COMPETING CONTINUATION	$195,696
														Subtotal = $195,696

Issue Date FY: 2025 ( Subtotal = $195,696 )
2025	2025	RHODE ISLAND HOSPITAL	593 EDDY ST	PROVIDENCE	RI	02903	PROVIDENCE	USA	Drug Use and Addiction Research Programs	000	4	5/13/2025	NON-COMPETING CONTINUATION	$195,696
														Subtotal = $195,696

Issue Date FY: 2024 ( Subtotal = $260,389 )
2024	2024	RHODE ISLAND HOSPITAL	593 EDDY ST	PROVIDENCE	RI	02903	PROVIDENCE	USA	Drug Use and Addiction Research Programs	002	3	9/9/2024	SUPPLEMENT FOR EXPANSION	$65,365
2024	2024	RHODE ISLAND HOSPITAL	593 EDDY ST	PROVIDENCE	RI	02903	PROVIDENCE	USA	Drug Use and Addiction Research Programs	000	3	5/9/2024	NON-COMPETING CONTINUATION	$195,024
2024	2024	RHODE ISLAND HOSPITAL	593 EDDY ST	PROVIDENCE	RI	02903	PROVIDENCE	USA	Drug Use and Addiction Research Programs	001	3	7/31/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $260,389

Issue Date FY: 2023 ( Subtotal = $195,360 )
2023	2023	RHODE ISLAND HOSPITAL	593 EDDY ST	PROVIDENCE	RI	02903	PROVIDENCE	USA	Drug Use and Addiction Research Programs	000	2	5/11/2023	NON-COMPETING CONTINUATION	$195,360
														Subtotal = $195,360

Issue Date FY: 2022 ( Subtotal = $195,017 )
2022	2022	RHODE ISLAND HOSPITAL	593 EDDY ST	PROVIDENCE	RI	02903	PROVIDENCE	USA	Drug Use and Addiction Research Programs	000	1	5/23/2022	NEW	$195,017
														Subtotal = $195,017

Grand Total All Awards = $1,042,158

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

Award Number: K23DA055695

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 06/01/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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