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Assessing pharmacokinetic and pharmacodynamic variability of Δ9-tetrahydrocannabinol delivered from vaping products with and without concurrent use of nicotine

Award Number: R01DA057228
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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Assessing pharmacokinetic and pharmacodynamic variability of Δ9-tetrahydrocannabinol delivered from vaping products with and without concurrent use of nicotine - PROJECT SUMMARY There is a growing trend in the use of vaping devices used to administer liquid concentrates containing Δ9- tetrahydrocannabinol (THC). However, there is a gap in our knowledge and understanding of the pharmacokinetics (PK) and pharmacodynamics (PD) of THC delivered from this new generation of cannabis products. The literature on nicotine vaping has clearly shown that vaping product characteristics and user behaviors influence the PK/PD of vaped substances. Additionally, most cannabis consumers who vape liquid cannabis concentrates also report concurrent use of nicotine-containing vaping products (e-cigarettes). Building on strategies used to establish the evidence base on the PK/PD of nicotine-containing vaping products, this project will examine the PK/PD profile of THC-containing liquid concentrates delivered through vaping devices WITH and WITHOUT co-use of nicotine through completion of three specific aims: Aim 1 is to examine how vaping product characteristics and user behaviors impact the PK/PD of THC. Aim 1 will characterize the PK/PD variability in real-world settings. This will be achieved by using a mobile laboratory bus to recruit current vapers of THC-containing liquids and examine their PK/PD. Study participants will use their own commercially obtained THC cartridges ad lib through their usual vaping device. In Aim 2, a controlled laboratory paradigm will be used to compare the PK/PD profiles of equivalent standard THC units delivered from vaping liquids vs smoked cannabis. Aim 3 will assess the PK/PD profiles of THC vaping liquids sequentially administered with nicotine using a double-blind, placebo-controlled, randomized within-subjects trial design. This highly innovative approach will offer a significant advantage over the existing literature by combining naturalistic observational methods and controlled laboratory assessments to provide a depiction of the PK/PD of THC delivered through vaping liquids. The findings will be directly relevant for the existing cannabis market and consumers who use these products. This project will improve our understanding of the PK/PD effects of THC by characterizing the PK/PD profiles of THC vaping liquid formulations and devices used by cannabis consumers, establishing differences in the effects of these products relative to smoked cannabis, and providing necessary data on how co-use of vaped nicotine and THC may impact THC PK/PD. Data from this project will be highly relevant for informing future regulatory and consumer safety efforts for THC vaping products.


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 = $651,235 )
2025	2025	HEALTH RESEARCH, INC.	665 ELM ST	BUFFALO	NY	14203	ERIE	USA	Drug Use and Addiction Research Programs	000	4	7/2/2025	NON-COMPETING CONTINUATION	$651,235
														Subtotal = $651,235

Issue Date FY: 2024 ( Subtotal = $666,413 )
2024	2024	HEALTH RESEARCH, INC.	665 ELM ST	BUFFALO	NY	14203	ERIE	USA	Drug Use and Addiction Research Programs	001	3	6/21/2024	NON-COMPETING CONTINUATION	$666,413
2024	2023	HEALTH RESEARCH, INC.	665 ELM ST	BUFFALO	NY	14203	ERIE	USA	Drug Use and Addiction Research Programs	000	2	2/27/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $666,413

Issue Date FY: 2023 ( Subtotal = $696,738 )
2023	2023	HEALTH RESEARCH, INC.	ELM & CARLTON ST	BUFFALO	NY	14263	ERIE	USA	Drug Use and Addiction Research Programs	003	2	8/15/2023	NON-COMPETING CONTINUATION	$0
2023	2023	HEALTH RESEARCH, INC.	ELM & CARLTON ST	BUFFALO	NY	14263	ERIE	USA	Drug Use and Addiction Research Programs	002	2	6/15/2023	NON-COMPETING CONTINUATION	$696,738
2023	2022	HEALTH RESEARCH, INC.	ELM AND CARLTON ST	BUFFALO	NY	14263	ERIE	USA	Drug Use and Addiction Research Programs	000	1	1/9/2023	NEW	$0
2023	2022	HEALTH RESEARCH, INC.	ELM & CARLTON ST	BUFFALO	NY	14263	ERIE	USA	Drug Use and Addiction Research Programs	001	1	6/14/2023	NEW	$0
														Subtotal = $696,738

Issue Date FY: 2022 ( Subtotal = $706,151 )
2022	2022	HEALTH RESEARCH, INC.	ELM AND CARLTON ST	BUFFALO	NY	14263	ERIE	USA	Drug Use and Addiction Research Programs	000	1	9/20/2022	NEW	$706,151
														Subtotal = $706,151

Grand Total All Awards = $2,720,537

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Assessing pharmacokinetic and pharmacodynamic variability of Δ9-tetrahydrocannabinol delivered from vaping products with and without concurrent use of nicotine

Award Number: R01DA057228

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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