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PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:
A Randomized Within-Subject Cross-Over Study to Compare Short-Term PK/PD Effects of Vaping THC-containing Liquids vs. Smoked Cannabis

Clinical Trial Summary

We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members 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

Clinical Trial Description

PRIMARY OBJECTIVE: I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design. SECONDARY OBJECTIVES: I. Safety PRIMARY OBJECTIVE: I. Compare the PK/PD profiles of delta-9 tetrahydrocannabinol (THC) from equivalent standard THC doses (30mg) administered as vaped THC liquid vs. smoked cannabis using a within-subject design. SECONDARY OBJECTIVES: I. Safety ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06055231
Study type Interventional
Source Roswell Park Cancer Institute
Contact Danielle Smith
Phone 8772757724
Email askroswell@roswellpark.org
Status Not yet recruiting
Phase Phase 1
Start date June 15, 2024
Completion date June 15, 2026
View Details
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