This phase I trial compares vaping THC containing liquids to smoking cannabis to reduce systemic exposure to THC in patients who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can serve as an important benchmark for evaluating the delivery and effects of THC vaping products and, their relative safety.
Additional locations may be listed on ClinicalTrials.gov for NCT06055231.
Locations matching your search criteria
United States
New York
Buffalo
Roswell Park Cancer InstituteStatus: Approved
Contact: Danielle M. Smith
Phone: 716-845-8403
PRIMARY OBJECTIVE:
I. Compare systemic exposure totetrahydrocannabinol (THC) from vaping THC liquids vs. smoked cannabis.
SECONDARY OBJECTIVES:
I. Safety
II. Assessment of differences in puffing behaviors.
III. Short-term subjective drug effects.
IV. Cognitive performance
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. 7 to 14 days later patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. Patients also undergo blood sample collection throughout the study.
ARM II: Patients receive a cannabis joint and smoke the provided joint in up to 10 minutes. 7 to 14 days later patients receive a vape device with THC containing liquid and consume the provided amount in up to 10 minutes. Patients also undergo blood sample collection throughout the study.
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorDanielle M. Smith
