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

NCT06055231 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: I 3409223R01DA057228
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Incidence of adverse events

  Up to 360 minutes after consuming product

• Puffing behaviors

  Through study completion, an average of 14 days

• Short term effects of THC

  Through Study completion, an average of 14 days

• Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST)

  Through study completion, an average of 14 days

• Paced Auditory Serial Addition Task (PASET)

  Through study completion , an average of 14 days

Study Arms (2)

Arm 1 (Vape followed by Joint)

EXPERIMENTAL

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.

Behavioral: Vape device; Drug: Marijuana via joint

Arm II (Joint followed by Vape)

EXPERIMENTAL

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.

Behavioral: Joint; Drug: Marijuana via vape device

Interventions

Vape device BEHAVIORAL

Consume THC via vape defice

Also known as: Behavioral Conditioning therapy, Behavioral Modification

Arm 1 (Vape followed by Joint)

Joint BEHAVIORAL

Consume THC via joint

Also known as: Behavior Conditioning Therapy, Behavior Modification

Arm II (Joint followed by Vape)

Marijuana via joint DRUG

Given via joint

Also known as: Cannibis

Arm 1 (Vape followed by Joint)

Marijuana via vape device DRUG

Given via vape device

Also known as: Cannibis

Arm II (Joint followed by Vape)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Roswell Park Cancer Institute: lead

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Danielle Smith

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Smith

CONTACT

8772757724; askroswell@roswellpark.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 26, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03