Sunday, May 19, 2024 5/19/2024

A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail

Award Number: UG1DA050077
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Abstract The proposed study is a Type 1 hybrid effectiveness-implementation trial. Early adopters from the Maryland extended-release naltrexone (XR-NTX) initiative and additional counties who are willing to provide CAM2038, a new extended-release-buprenorphine (XR-B) formulation will participate in a randomized controlled trial conducted in 7 counties (10 jails) throughout the state of Maryland, in which 240 incarcerated men and women will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program. Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received). Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. To use a learning collaborative involving all 7 RCT county jurisdictions as well as 3 additional counties that selected not to participate in the randomized trial to understand factors related to: (a) acceptability of providing long-acting agonists and antagonists in jail settings; and (b) feasibility of providing medication continuity of care from jail to community treatment providers. Aim 3. Calculate the cost to the correctional health system of implementing an XR-B or XR-NTX program, and determine the relative value of each strategy, including the costs associated with the subsequent interventions in the community, from a state- policymaker and societal perspective. The proposed study is innovative because it would be the first randomized clinical trial in the US assessing 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, HIV/AIDS infection, and re-incarceration. Finally, understanding how to expand acceptance of medications for opioid use disorder in jails, particularly long-acting medications, has far-reaching implications for treatment expansion in this 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: 2024 ( Subtotal = $0 )
2024	2023	FRIENDS RESEARCH INSTITUTE, INC.	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	000	5	5/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $2,411,241 )
2023	2023	FRIENDS RESEARCH INSTITUTE INC	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	000	5	4/28/2023	NON-COMPETING CONTINUATION	$1,967,149
2023	2023	FRIENDS RESEARCH INSTITUTE INC	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	001	5	5/1/2023	SUPPLEMENT FOR EXPANSION	$444,092
2023	2023	FRIENDS RESEARCH INSTITUTE INC	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	002	5	9/14/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $2,411,241

Issue Date FY: 2022 ( Subtotal = $2,847,930 )
2022	2022	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	002	4	9/14/2022	SUPPLEMENT FOR EXPANSION	$678,563
2022	2022	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	001	4	4/30/2022	NON-COMPETING CONTINUATION	$2,169,367
2022	2021	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	000	3	10/25/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $2,847,930

Issue Date FY: 2021 ( Subtotal = $2,381,441 )
2021	2021	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	001	3	9/21/2021	SUPPLEMENT FOR EXPANSION	$165,428
2021	2021	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	000	3	4/8/2021	NON-COMPETING CONTINUATION	$2,216,013
														Subtotal = $2,381,441

Issue Date FY: 2020 ( Subtotal = $2,231,473 )
2020	2020	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	001	2	4/8/2020	NON-COMPETING CONTINUATION	$2,231,473
2020	2019	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	000	1	2/19/2020	NEW	$0
														Subtotal = $2,231,473

Issue Date FY: 2019 ( Subtotal = $1,699,618 )
2019	2019	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	000	1	7/15/2019	NEW	$1,699,618
2019	2019	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Abuse and Addiction Research Programs	001	1	8/12/2019	NEW	$0
														Subtotal = $1,699,618

Grand Total All Awards = $11,571,703

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A comparative effectiveness trial of extended release naltrexone versus extended-release buprenorphine with individuals leaving jail

Award Number: UG1DA050077

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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