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Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment

Award Number: R01DA040636
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2016
PERIOD OF PERFORMANCE END DATE: 04/30/2025

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Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment - DESCRIPTION (provided by applicant): Disorders involving opioid use are a severe problem among jail and prison inmates. Inmates in the US, Canada, Australia, and many European and Asian nations have disproportionately higher rates of opioid use disorders than their general populations. Scarce resources are provided for corrections-based substance use treatment in many nations, and many inmates with OUDs remain untreated. The use of long-acting, injectable naltrexone (XR-NTX) may be a promising form of treatment for pre-release prisoners. Naltrexone blocks the intoxicating and reinforcing effects of opioids, but has no opioid-like effects. This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication. Project implementation will occur at five pre-release prisons under the jurisdiction of the Maryland Department of Public Safety and Correctional Services (MDPSCS): 1) Metropolitan Transition Center (MTC) for men; 2) Baltimore Pre-Release Unit (BPRU) for men; 3) Jessup Pre- Release Unit (JPRU) for men; 4) Baltimore City Correctional Center (BCCC) and 5) Maryland Correctional Institution (MCI) for Women. Following initial screening, informed consent, and medical examination, pre- release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR- NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence. All participants will be confirmed opiate-free by urine test and negative naloxone and oral naltrexone tests, and evaluated monthly for seven months and 12 months after release from prison. The proposed study has two specific aims: Aim1. To compare the two study conditions in terms of: a) XR-NTX treatment adherence; b) opioid use; c) criminal activity; d) re-arrest; e) re-incarceration; and f) HIV risk-behaviors (i. needle use; ii. risky sexual behaviors). Aim 2. To determine if the number of months of post-release XR-NTX treatment is related to outcome (a-f above), and if so, is there a point at which XR-NTX v. Non-XR-NTX equilibrates? This would help determine the number of injections, important because of XR-NTX cost. Many individuals in the criminal justice system drop out of treatment and therefore increasing ways to improve adherence by attempting to: 1) expand capacity; and 2) implement access by providing treatment at their place of residence may positively impact outcomes.


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 = $0 )
2025	2021	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	5	6/22/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	FRIENDS RESEARCH INSTITUTE, INC.	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	5	4/8/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	FRIENDS RESEARCH INSTITUTE INC	1040 PARK AVE	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	5	3/28/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $519,501 )
2021	2021	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	5	3/18/2021	NON-COMPETING CONTINUATION	$519,501
														Subtotal = $519,501

Issue Date FY: 2020 ( Subtotal = $637,817 )
2020	2020	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	4	3/31/2020	NON-COMPETING CONTINUATION	$637,817
														Subtotal = $637,817

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	3	3/26/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $631,303 )
2018	2018	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	3	4/24/2018	NON-COMPETING CONTINUATION	$631,303
														Subtotal = $631,303

Issue Date FY: 2017 ( Subtotal = $631,303 )
2017	2017	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	2	4/25/2017	NON-COMPETING CONTINUATION	$568,172
2017	2017	FRIENDS RESEARCH INSTITUTE, INC	1040 PARK AVE STE 103	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	001	2	5/22/2017	NON-COMPETING CONTINUATION	$63,131
														Subtotal = $631,303

Issue Date FY: 2016 ( Subtotal = $644,996 )
2016	2016	FRIENDS RESEARCH INSTITUTE, INC	505 BALTIMORE AVENUE	BALTIMORE	MD	21204	BALTIMORE	USA	Drug Use and Addiction Research Programs	001	1	8/9/2016	NEW	$29,891
2016	2016	FRIENDS RESEARCH INSTITUTE, INC	505 BALTIMORE AVENUE	BALTIMORE	MD	21204	BALTIMORE	USA	Drug Use and Addiction Research Programs	000	1	8/3/2016	NEW	$615,105
														Subtotal = $644,996

Grand Total All Awards = $3,064,920

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Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment

Award Number: R01DA040636

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2016

PERIOD OF PERFORMANCE END DATE: 04/30/2025

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