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Novel Approaches to Opiate Use Reduction

Award Number: R01DA048069
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2020
PERIOD OF PERFORMANCE END DATE: 01/31/2025

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Novel Approaches to Opiate Use Reduction - Research Summary The United States is facing an opiate epidemic that is spiraling out of control, with a recent CDC report finding that drug overdoses kill one and a half times more people annually than motor vehicle accidents. This epidemic has been driven, in part, by the high prevalence of chronic pain conditions. The interconnected problems of chronic pain and the opiate epidemic are expected to persist and even worsen in the short term. Given these complex and deadly challenges, patients and medical providers are in desperate need of solutions. Simultaneously, the wide availability of medical and recreational cannabis has increased dramatically within the past decade as a result of legalization in 2 states. Data suggest that management of chronic pain is a driving motivation among medical cannabis users, and recent studies suggest that medical cannabis users report cannabis to be more effective at managing pain as compared to opiates. As a result, pain patients are increasingly turning to cannabis as a form of treatment. At the same time, highly respected institutions like the National Academy of Sciences have published systematic reviews indicating that there is substantial evidence that cannabis products are actually effective in the treatment of pain. Despite the burgeoning body of evidence that supports the idea that cannabis may play a helpful role in the chronic pain and opiate epidemic, prospective studies on the effectiveness and safety profile of cannabis as a treatment for reducing opiate use are virtually non-existent in the U.S. The proposed research is timely and would address a glaring gap in the knowledge base in ways that could potentially have an important public health impact. In light of the current legal climate prohibiting a traditional randomized controlled trial with legal market cannabis products, we propose a patient-centered and highly innovative adaptive intervention design to examine the effectiveness of the cannabis products that patients are already using to reduce reliance on opiates. Consistent with federal laws, we will not be involved in the dispensing of the products and we will not direct the administration or dosing of the products. Our overarching aim is to compare three broad classes of orally administered products (i.e., “edibles”): a THC only product, a product that has a 1:1 THC to CBD ratio, and a CBD only product over the course of 12 weeks in a sample of individuals who want to reduce their opiate use and plan to use cannabis to do so. The primary clinical outcome is opiate use reduction, and the secondary outcome is pain control. We will also conduct acute laboratory sessions in our mobile pharmacology lab to directly examine mechanisms that may mediate the effect of the cannabis products on the clinical 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: 2024 ( Subtotal = $591,853 )
2024	2024	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	000	5	1/17/2024	NON-COMPETING CONTINUATION	$532,668
2024	2024	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	001	5	4/26/2024	NON-COMPETING CONTINUATION	$59,185
														Subtotal = $591,853

Issue Date FY: 2023 ( Subtotal = $620,598 )
2023	2023	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	000	4	2/1/2023	NON-COMPETING CONTINUATION	$620,598
														Subtotal = $620,598

Issue Date FY: 2022 ( Subtotal = $628,448 )
2022	2022	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	001	3	3/23/2022	NON-COMPETING CONTINUATION	$62,846
2022	2022	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	000	3	1/19/2022	NON-COMPETING CONTINUATION	$565,602
														Subtotal = $628,448

Issue Date FY: 2021 ( Subtotal = $628,179 )
2021	2021	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	004	2	3/22/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$640,563
2021	2021	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	002	2	3/3/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$61,431
2021	2021	REGENTS OF THE UNIVERSITY OF COLORADO, THE	13001 E 17TH PLACE F428	AURORA	CO	80045	ADAMS	USA	Drug Use and Addiction Research Programs	001	2	1/25/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$566,748
2021	2020	REGENTS OF THE UNIVERSITY OF COLORADO, THE	3100 MARINE ST STE 481 572 UCB	BOULDER	CO	80309	BOULDER	USA	Drug Use and Addiction Research Programs	000	1	1/22/2021	NEW	$0
2021	2020	REGENTS OF THE UNIVERSITY OF COLORADO, THE	3100 MARINE ST STE 481 572 UCB	BOULDER	CO	80309	BOULDER	USA	Drug Use and Addiction Research Programs	003	1	3/22/2021	NEW	-$640,563
														Subtotal = $628,179

Issue Date FY: 2020 ( Subtotal = $640,563 )
2020	2020	REGENTS OF THE UNIVERSITY OF COLORADO, THE	3100 MARINE ST STE 481 572 UCB	BOULDER	CO	80309	BOULDER	USA	Drug Use and Addiction Research Programs	000	1	3/27/2020	NEW	$640,563
														Subtotal = $640,563

Grand Total All Awards = $3,109,641

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Novel Approaches to Opiate Use Reduction

Award Number: R01DA048069

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2020

PERIOD OF PERFORMANCE END DATE: 01/31/2025

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