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A comparative effectiveness trial of sublingual versus extended-release buprenorphine with individuals leaving a carceral setting

Award Number: R01DA058674
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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A comparative effectiveness trial of sublingual versus extended-release buprenorphine with individuals leaving a carceral setting - Abstract Although previous research has demonstrated the effectiveness of initiating medications for opioid use disorder (MOUDs) during incarceration, there has been very little adoption nationwide of this practice. Extended-release buprenorphine (XR-B) is a promising intervention for the treatment of OUDs in carceral settings. Individuals with OUDs re-entering the community are at an elevated risk for overdose and death from relapse to opioid use among other opioid-related harms. This proposal builds on the current investigators experience conducting clinical trials using both XR-B and sublingual-buprenorphine-naloxone (SL-B) with individuals in jail and prison. This proposed study is a randomized controlled trial of XR-B vs. SL-B in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n = 120) or SL-B (n = 120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and final long-term follow-up at 12-months. The study has three aims: Aim 1. Compare the effectiveness of XR-B vs. SL-B in terms of: Primary Outcome. (a) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use using Timeline Followback; and iii. time to opioid relapse). Secondary Outcomes. (b) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use using Timeline Followback; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration). Aim 2. To calculate the cost to the state and/or jail/city health system of implementing XR-B and SL-B, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective. Aim 3. Explore barriers and facilitators to XR-B/SL-B implementation in jail: (1) dose induction; (2) diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another facility; (4) staffing (both custody and medical) needs for daily versus XR-B buprenorphine dosing; and (5) patient preference for XR-B versus SL-B. The proposed study would be innovative because it would be the first large scale RCT in the US assessing effectiveness and cost effectiveness of XR-B versus SL-B with individuals in a jail who are re-entering community. Understanding how to expand acceptance of buprenorphine in jails, has far-reaching implications for expanding treatment access in jail.


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: 2025 ( Subtotal = $1,129,361 )
2025	2025	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	3	7/18/2025	NON-COMPETING CONTINUATION	$1,129,361
														Subtotal = $1,129,361

Issue Date FY: 2024 ( Subtotal = $1,086,043 )
2024	2024	FRIENDS RESEARCH INSTITUTE, INC.	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	001	2	5/24/2024	NON-COMPETING CONTINUATION	$1,086,043
2024	2023	FRIENDS RESEARCH INSTITUTE, INC.	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	1	2/2/2024	NEW	$0
														Subtotal = $1,086,043

Issue Date FY: 2023 ( Subtotal = $881,830 )
2023	2023	FRIENDS RESEARCH INSTITUTE INC	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	1	9/15/2023	NEW	$881,830
														Subtotal = $881,830

Grand Total All Awards = $3,097,234

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A comparative effectiveness trial of sublingual versus extended-release buprenorphine with individuals leaving a carceral setting

Award Number: R01DA058674

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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