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Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

Award Number: UG3DA048388
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2024

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Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder - Project Summary/Abstract: In response to the national public health crisis of opioid misuse and addiction, the National Institute of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative in April 2018 to aggressively drive the development of scientific tools that will end the opioid crisis by accelerating effective discoveries through the FDA for drug approval. The HEAL Initiative development programs over the next five years are expected to result in 15 Investigational New Drugs (INDs) applications and at least 5 New Drug Applications (NDAs). The NIH HEAL Initiative has issued this RFA-DA-19-002 under the National Institute on Drug Abuse (NIDA) to “support the discovery and development of medications to prevent and treat opioid use disorders (OUD) and overdose.” INSYS Development Company, Inc. (INSYS) has developed cannabidiol oral solution, which shows promise as a novel medication for prevention of relapse that addresses one of the five opportunities specified to improve treatment options (Opportunity 4). INSYS, in collaboration with KAI Research, Inc., plans to initiate the clinical develop program of Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder consisting of three proposed clinical trials under the UG3/UH3 Phases: 1. For the UG3 phase, INSYS in collaboration with principal investigator Edythe London, PhD (UCLA) will conduct a randomized, double-blind, placebo controlled, dose-ranging study of cannabidiol oral solution on cue-induced cravings, modulation of withdrawal, alteration in negative affect states, relapse to opioid use, and treatment retention in patients with OUD receiving buprenorphine treatment in a residential drug treatment facility. The findings from this study will be used to support the transition to the UH3 phase. 2. For the UH3 phase, INSYS in collaboration with principal investigator Kathleen Brady, MD, PhD (MUSC) will conduct two studies in an outpatient setting: • A randomized, double-blind, placebo-controlled, parallel-group study of cannabidiol oral capsule as adjunctive therapy to buprenorphine ± naloxone for treatment in patients with opioid use disorder. • A randomized, double-blind, active-controlled, parallel-group, double-dummy, proof-of- concept study of cannabidiol oral capsule compared to naltrexone as monotherapy for treatment in patients with opioid use disorder.


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 = -$332 )
2025	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	3	4/23/2025	NON-COMPETING CONTINUATION	-$332
														Subtotal = -$332

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	3	12/28/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,083,127 )
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Drug Use and Addiction Research Programs	002	3	8/4/2022	NON-COMPETING CONTINUATION	$0
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Drug Use and Addiction Research Programs	001	3	11/30/2021	NON-COMPETING CONTINUATION	$108,314
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Drug Use and Addiction Research Programs	000	3	11/24/2021	NON-COMPETING CONTINUATION	$974,813
														Subtotal = $1,083,127

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Drug Use and Addiction Research Programs	001	2	1/6/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,206,366
2021	2019	INSYS DEVELOPMENT COMPANY, INC.	410 S BENSON LN	CHANDLER	AZ	85224	MARICOPA	USA	Drug Use and Addiction Research Programs	000	1	1/6/2021	NEW	-$1,206,366
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $1,206,366 )
2019	2019	INSYS DEVELOPMENT COMPANY, INC.	1333 S SPECTRUM BLVD STE 100	CHANDLER	AZ	85286	MARICOPA	USA	Drug Use and Addiction Research Programs	000	1	5/7/2019	NEW	$1,206,366
														Subtotal = $1,206,366

Grand Total All Awards = $2,289,161

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Cannabidiol Effects on Craving and Relapse Prevention in Opioid Use Disorder

Award Number: UG3DA048388

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 05/15/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2024

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