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Re-Engineering Systems to Treat Opioid use Disorder for Everyone (RESTORE): A Pilot Randomized Controlled Trial

Award Number: DP1DA058978
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2023
PERIOD OF PERFORMANCE END DATE: 07/31/2029

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Re-Engineering Systems to Treat Opioid use Disorder for Everyone (RESTORE): A Pilot Randomized Controlled Trial - I am a well-published, early stage medical sociologist proposing to investigate the feasibility, acceptability, and preliminary efficacy of an innovative, multilevel community-engaged opioid use disorder (OUD) treatment intervention. This study will apply my understanding of community needs and OUD, to test a scalable novel intervention in a real world setting, leveraging my role as a leader in this field to disseminate findings and improve treatment access nationwide. Significant federal funding has expanded access to OUD treatment services in community health clinics (CHCs) that provide care to medically underserved populations and areas but barriers to accessing care persist. I propose to prepare for a fully powered clinical trial by testing whether a combined organization and patient-level intervention (Re-Engineering Systems to Treat Opioid Use Disorder for Everyone – RESTORE) that targets patient-, provider-, and system-level barriers to OUD treatment is feasible and acceptable in the context of CHCs. Community engagement will be continuous, exemplified by the use of peer navigators to connect patients to care and treatment. RESTORE will be based in Southern and Northern California—epicenters of the nation’s opioid crisis. Project Phases, guided by cutting edge implementation science, include 1) a qualitative investigation into provider and patient barriers to and facilitators of CHCs’ provision of buprenorphine treatment for OUD; 2) the operationalization of RESTORE into routine care, using preliminary findings from Phase I; and 3) a pilot stepped-wedge randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of RESTORE, as well as the protocols, procedures and training in CHCs. This study has the potential to improve effective treatment rates in CHCs and provide an evidence-based intervention to be tested at scale across multiple states in the U.S., thereby increasing treatment access, improving patient outcomes, and saving lives.


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 = $0 )
2026	2024	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Drug Use and Addiction Research Programs	000	2	1/27/2026	OTHER REVISION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Drug Use and Addiction Research Programs	000	2	6/2/2025	TERMINATION	$0
2025	2024	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Drug Use and Addiction Research Programs	001	2	7/8/2025	OTHER REVISION	$0
2025	2024	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Drug Use and Addiction Research Programs	002	2	8/11/2025	OTHER REVISION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,053,500 )
2024	2024	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Drug Use and Addiction Research Programs	001	2	7/19/2024	NON-COMPETING CONTINUATION	$1,053,500
2024	2023	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Drug Use and Addiction Research Programs	000	1	7/18/2024	NEW	$0
														Subtotal = $1,053,500

Issue Date FY: 2023 ( Subtotal = $1,053,500 )
2023	2023	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR MC1947	SAN DIEGO	CA	92182	SAN DIEGO	USA	Drug Use and Addiction Research Programs	000	1	8/31/2023	NEW	$1,053,500
														Subtotal = $1,053,500

Grand Total All Awards = $2,107,000

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Re-Engineering Systems to Treat Opioid use Disorder for Everyone (RESTORE): A Pilot Randomized Controlled Trial

Award Number: DP1DA058978

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2023

PERIOD OF PERFORMANCE END DATE: 07/31/2029

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