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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06055231
• Other study ID #: I 3409223
• Secondary ID: R01DA057228
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 15, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: April 2024
• Source: Roswell Park Cancer Institute
• Contact: Danielle Smith
• Phone: 8772757724
• Email: askroswell[@]roswellpark.org
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma
• Marijuana Abuse

Intervention

Behavioral:
• Vape device
Consume THC via vape defice
• Joint
Consume THC via joint

Drug:
• Marijuana via vape device
Given via vape device
• Marijuana via joint
Given via joint

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Blood samples will be collected for plasma levels of THC. All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex	From baseline to 360 minutes after consuming product
Primary	Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360)	Blood samples will be collected for plasma levels of THC. All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex.	From baseline to 360 minutes after consuming product
Primary	Time to maximum concentration of THC in plasma (Tmax)	Blood samples will be collected for plasma levels of THC.All individual pharmacokinetic (PK) parameters will be derived from plasma THC concentrations-versus-time data by non-compartmental analysis using Phoenix WinNonlin, corrected for baseline THC concentrations. Mean differences for each measure will be compared between the experimental (THC vaping) and active control (smoked cannabis) conditions, and by sex.	From baseline to 360 minutes after consuming product
Secondary	Incidence of adverse events	Number of subjects who experienced an adverse event during the study .	Up to 360 minutes after consuming product
Secondary	Puffing behaviors	Measure changes in subject puffing behavior by mean number of puffs and duration	Through study completion, an average of 14 days
Secondary	Short term effects of THC	The Drug Effect Questionnaire (DEQ) rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use.	Through Study completion, an average of 14 days
Secondary	Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST)	computerized sensitive and valid assessment of cognitive dysfunction that correlates with real-world functional ability to complete daily tasks. The outcome is the total number of correct responses.	Through study completion, an average of 14 days
Secondary	Paced Auditory Serial Addition Task (PASET)	a validated measure used to assess attention, concentration, working memory, and information processing.	Through study completion , an average of 14 days