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Repeated-dose behavioral intervention to reduce opioid overdose: a two-site randomized-controlled efficacy trial

Award Number: R01DA045690
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary/Abstract The United States is amidst an epidemic of opioid overdose, including opioid analgesics, heroin, and illicitly- manufactured fentanyl and related synthetic opioids. Multiple interventions to address opioid overdose have been employed, such as lay access to naloxone to reverse opioid overdose, yet the number of people dying each year from opioid overdose continues to increase each year. In addition to efforts to reduce mortality, efforts are needed to reduce the occurrence of any opioid overdose, particularly given the rapidity of synthetic opioid overdoses, which may restrict the time available to intervene once an overdose occurs. Opioid stewardship activities, necessary to avert yet another generation affected by the opioid epidemic, may paradoxically contribute to the illicit opioid epidemic, and expanded access to opioid use disorder treatment, while essential, is limited by resources, stigma, and the willingness of patients to accept the intervention. The NIDA-funded pilot study of REBOOT (repeated dose behavioral intervention to reduce opioid overdose), a motivational interviewing-based brief intervention addressing experienced and witnessed overdose events, resulted in substantial reductions in the occurrence of any opioid overdose, as well as the number of opioid overdoses that occurred during 16 months of follow-up. This full trial of REBOOT includes two regions of the United States – San Francisco, largely unaffected by the fentanyl epidemic – and Boston, at the epicenter of fentanyl use, overdose, and mortality. REBOOT will enroll 300 persons with opioid use disorder who are currently using opioids, have previously received take-home naloxone, and are at high-risk for recurrent overdose. Participants will be randomized to the intervention or attention-control and seen every four months for 16 months, with interval assessments for overdose events, overdose risk factors, engagement in substance use disorder treatment, and substance use. Medical records will be reviewed to capture unreported overdose events, including death. Results will determine if addressing overdose through motivational interviewing can reduce the occurrence of overdose, contributing to efforts to respond to this national emergency.


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: 2022 ( Subtotal = $692,881 )
2022	2022	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	000	5	5/27/2022	NON-COMPETING CONTINUATION	$692,881
														Subtotal = $692,881

Issue Date FY: 2021 ( Subtotal = $831,492 )
2021	2021	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	000	4	3/17/2021	NON-COMPETING CONTINUATION	$831,492
														Subtotal = $831,492

Issue Date FY: 2020 ( Subtotal = $831,618 )
2020	2020	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	000	3	3/20/2020	NON-COMPETING CONTINUATION	$831,618
														Subtotal = $831,618

Issue Date FY: 2019 ( Subtotal = $969,640 )
2019	2019	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	000	2	3/19/2019	NON-COMPETING CONTINUATION	$811,238
2019	2019	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	001	2	8/2/2019	SUPPLEMENT FOR EXPANSION	$158,402
														Subtotal = $969,640

Issue Date FY: 2018 ( Subtotal = $716,100 )
2018	2018	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	000	1	6/15/2018	NEW	$716,100
2018	2018	PUBLIC HEALTH FOUNDATION ENTERPRISES, INC.	13300 CROSSROADS PKWY N STE 450	CITY OF INDUSTRY	CA	91746	LOS ANGELES	USA	Drug Abuse and Addiction Research Programs	001	1	9/18/2018	NEW	$0
														Subtotal = $716,100

Grand Total All Awards = $4,041,731

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Repeated-dose behavioral intervention to reduce opioid overdose: a two-site randomized-controlled efficacy trial

Award Number: R01DA045690

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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