NCT06055231

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	Vape device	Consume THC via vape defice
BEHAVIORAL	Joint	Consume THC via joint
DRUG	Marijuana via vape device	Given via vape device
DRUG	Marijuana via joint	Given via joint

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-03-15
• Completion: 2027-09-15
• First posted: 2023-09-26
• Last updated: 2026-03-05

Regulatory

• FDA-regulated drug study