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Development of a Longitudinal Observational Research Registry for the Study of Medicinal Cannabis Use and Health

Award Number: UM1DA059000
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: 06/01/2023
PERIOD OF PERFORMANCE END DATE: 04/30/2028

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Development of a Longitudinal Observational Research Registry for the Study of Medicinal Cannabis Use and Health - Due to changes in cannabis policy, most Americans now have access to an array of retail cannabis products. An estimated 5.5 million Americans are registered with state-regulated medical cannabis programs and the therapeutic use of federally legal hemp (e.g. CBD) products is widespread. Despite most states having legalized medicinal cannabis use, little is known about the characteristics of these patients, the cannabis products they use, or the patient-level health impact of their medicinal cannabis use. Filling these gaps in knowledge remains an urgent public health need. We propose to: 1) design and implement a prospective medicinal cannabis patient registry for longitudinal data collection. We will recruit a nationally representative cohort of patients newly initiating the use of cannabis for therapeutic purposes into a longitudinal observational research registry. We will assess patient demographics, cannabis product use, and a range of health outcomes prior to and repeatedly after initiation of medicinal cannabis use via web-based surveys. A subset of patients will complete intensive data collection via ecological momentary assessment (EMA) and/or provide biospecimens for clinical chemistry testing to determine the impact of medicinal cannabis use on daily functioning and symptom management in addition to potential unseen harms such as liver toxicity; 2) Establish a program of medicinal cannabis product testing based on adverse event reporting and other mentions of injury/harm in the patient registry or via surveillance of other data sources (e.g. poison control data, FDA warnings, online forum posts). Products associated with adverse events or other harms will be targeted for testing related to dose-label accuracy, cannabinoid content, and presence of contaminants; 3) Identify and integrate existing sources of data that can inform the health impacts of medicinal cannabis use. This includes electronic medical record (EMR) databases as well as prior and ongoing research projects of the study team (e.g., Realm of Caring Observational Research Registry); 4) Develop and implement a website that will include annual summary reports of the combined data, an application process for researcher access to de-identified data for the conduct of novel analyses, and an archive of published papers related to the health impacts of medicinal cannabis use. A pilot research program to fund scientists interested in probing the data repository will be established. Our team includes internationally recognized expertise in the comprehensive research methods proposed. The result of this project will be a rich data resource for understanding the health impacts of medicinal cannabis use. Data will include patient-level outcomes across a broad range of therapeutic purposes and include use of a variety of cannabis products. Data will help inform clinical decision making related to initiation of cannabis products, guidance on product, route of administration and dose selection, risks related to adverse events, injury/poisoning risk and abuse liability. Findings will also help local and federal government agencies develop effective policies, programs, and regulatory strategies to mitigate harms associated with the rapidly growing cannabis industry.


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 = $2,019,346 )
2025	2025	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	3	5/29/2025	NON-COMPETING CONTINUATION	$2,019,346
														Subtotal = $2,019,346

Issue Date FY: 2024 ( Subtotal = $2,038,178 )
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	2	4/23/2024	NON-COMPETING CONTINUATION	$2,038,178
														Subtotal = $2,038,178

Issue Date FY: 2023 ( Subtotal = $2,058,998 )
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Drug Use and Addiction Research Programs	000	1	5/31/2023	NEW	$2,058,998
														Subtotal = $2,058,998

Grand Total All Awards = $6,116,522

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Development of a Longitudinal Observational Research Registry for the Study of Medicinal Cannabis Use and Health

Award Number: UM1DA059000

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: 06/01/2023

PERIOD OF PERFORMANCE END DATE: 04/30/2028

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