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Repeated Administration of Cannabis Varying in THC and CBD: Effects on Abuse Liability, Experimental Pain and Plasma Endocannabinoids

Award Number: R01DA053332
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2029

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Repeated Administration of Cannabis Varying in THC and CBD: Effects on Abuse Liability, Experimental Pain and Plasma Endocannabinoids - The majority of the >1.2 million registered medical cannabis patients in the U.S. cite pain relief as their primary reason for using cannabis products. Although cannabis and its constituents (cannabinoids) have potential for the treatment of chronic pain, there are critical gaps in our knowledge regarding the effects of repeated cannabis administration on pain, abuse liability and circulating endogenous cannabinoid (eCBs) levels. The endocannabinoid system plays a critical role in CNS function, yet the impact of cannabis use on circulating eCBs is poorly understood. There is also little known about the effects of cannabis with varying concentrations of oral D9-tetrahydrocannabinol (THC) and cannabidiol (CBD), the two most commonly used cannabinoids by medical cannabis patients. This project is designed to answer three questions that will fill important voids in our understanding of sustained cannabis use: 1) does tolerance develop to the analgesic and abuse-related effects of repeatedly administered cannabis with varying ratios of THC and CBD, and is this tolerance reversible following a period of abstinence; 2) is abrupt cessation of cannabis with varying ratios of THC and CBD associated with withdrawal-induced hyperalgesia; 3) how does repeatedly administered cannabis with varying ratios of THC and CBD modulate levels of circulating eCBs, and are these changes associated with altered pain sensitivity and abuse liability? Prior to inpatient testing of cannabis administration, we will use contingency management procedures to engender sustained abstinence in healthy cannabis users in order to minimize existing tolerance. We will then enroll participants (N=100) inpatient for 15 days. They will be randomized to one of four cannabis conditions (n=25/group): 1) high THC:low CBD, 2) low THC:low CBD, 3) high THC:high CBD, 4) low THC:high CBD). Cannabis will be administered repeatedly for the first 7 inpatient days, followed by a 7-day abstinence period. The last study day (day 15) will re-introduce the assigned active cannabis dose to assess reversal of tolerance. At set time points within each condition, we will measure abuse-related effects (“Good Drug Effect”), plasma eCB levels and two distinct types of experimental pain: The Cold Pressor Test and Quantitative Sensory Testing Thermal Temporal Summation. Given the widespread use of cannabis for pain, understanding the consequences of daily repeated administration of cannabis with THC:CBD ratios that are representative of most medical cannabis products on pain, abuse liability, and eCBs is imperative. Tolerance to the abuse-related but not analgesic effects would be salutary, but the converse could contribute to the higher incidence of cannabis use disorder observed in medical cannabis patients. Similarly, if abrupt cannabis cessation exacerbates pain, medical cannabis patients will have difficulty ceasing cannabis use. Demonstrating a relationship between circulating eCBs and pain sensitivity can be used to help develop safe and effective cannabinoid-based pain treatments. Overall, this proposal will provide significant public health data for the large number of patients using a range of vaporized cannabis products for pain relief.


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 = $659,922 )
2026	2026	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	002	3	6/23/2026	SUPPLEMENT FOR EXPANSION	$18,711
2026	2026	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	001	3	6/12/2026	NON-COMPETING CONTINUATION	$641,211
2026	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	2	2/19/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $659,922

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	2	8/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC.	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	2	5/22/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $663,374 )
2023	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	003	2	7/19/2023	NON-COMPETING CONTINUATION	$0
2023	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	004	2	7/31/2023	NON-COMPETING CONTINUATION	$0
2023	2023	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	002	2	5/19/2023	NON-COMPETING CONTINUATION	$663,374
2023	2022	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	1	3/6/2023	NEW	$0
2023	2022	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	001	1	3/9/2023	NEW	$0
														Subtotal = $663,374

Issue Date FY: 2022 ( Subtotal = $678,240 )
2022	2022	RESEARCH FOUNDATION FOR MENTAL HYGIENE INC	1051 RIVERSIDE DR	NEW YORK	NY	10032	NEW YORK	USA	Drug Use and Addiction Research Programs	000	1	8/11/2022	NEW	$678,240
														Subtotal = $678,240

Grand Total All Awards = $2,001,536

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Repeated Administration of Cannabis Varying in THC and CBD: Effects on Abuse Liability, Experimental Pain and Plasma Endocannabinoids

Award Number: R01DA053332

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2029

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