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

Roswell Park Comprehensive Cancer Center

Status and phase: Begins enrollment this month; Phase 1

Conditions: Cigarette Smoking-Related Carcinoma

Treatments: Behavioral: Vape device; Drug: Marijuana via joint; Behavioral: Joint; Drug: Marijuana via vape device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06055231

I 3409223

R01DA057228 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age >= 21 years of age
• Report concurrent use of commercial (medical or recreational) smoked cannabis and THC vaping cartridges for at least 3 months prior to enrollment
• Report smoking cannabis and THC- vaping liquid use at the potency level of the study product at least weekly (4x/month)
• Report of not currently trying to become pregnant (females). Women of childbearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
• Willing to complete a THC saliva test to check for recent use (NarcoCheck Ref#:NCE-STHC-1) and semi -quantitative urinary tetrahydrocannabinol-carboxylic acid (THCA) rapid test (NarcoCheck® THC PreDosage) during baseline testing, prior to receiving any study-related products
• Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion criteria

• • Illegal or non-prescription drug use within the past 90 days. As detected by NacroCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product

  • Report 2 or more drinking occasions/week with 4 or more drinks/occasion
  • Report of daily nicotine use
  • Current or prior diagnosis of any psychotic disorders
  • Current or prior diagnosis of chronic heart conditions
  • Current or prior diagnosis of any respiratory condition
  • Pregnant or currently trying to become pregnant (females)
  • Detection level 4-5 (>300 ng/mL) from a semi-quantitative urinary THCA rapid test (NarcoCheck® THC PreDosage)
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm 1 (Vape followed by Joint)

Experimental group

Description:

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.

Treatment:

Drug: Marijuana via joint

Behavioral: Vape device

Arm II (Joint followed by Vape)

Experimental group

Description:

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.

Treatment:

Drug: Marijuana via vape device

Behavioral: Joint