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

March 4, 2026 updated by: Roswell Park Cancer Institute

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (Vape followed by Joint)
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
Consume THC via vape defice
Other Names:
  • Behavioral Modification
  • Behavioral Conditioning therapy
Drug: Marijuana via joint
Given via joint
Other Names:
  • Cannibis
Experimental: Arm II (Joint followed by Vape)
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
Consume THC via joint
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
Drug: Marijuana via vape device
Given via vape device
Other Names:
  • Cannibis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: From baseline to 360 minutes after consuming product
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)
Time Frame: From baseline to 360 minutes after consuming product
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)
Time Frame: From baseline to 360 minutes after consuming product
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 360 minutes after consuming product
Number of subjects who experienced an adverse event during the study .
Up to 360 minutes after consuming product
Puffing behaviors
Time Frame: Through study completion, an average of 14 days
Measure changes in subject puffing behavior by mean number of puffs and duration
Through study completion, an average of 14 days
Short term effects of THC
Time Frame: Through Study completion, an average of 14 days
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
Cognitive Performance as assessed by the Digit Symbol Substitution Task (DSST)
Time Frame: Through study completion, an average of 14 days
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
Paced Auditory Serial Addition Task (PASET)
Time Frame: Through study completion , an average of 14 days
a validated measure used to assess attention, concentration, working memory, and information processing.
Through study completion , an average of 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Danielle Smith, Roswell Park Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

September 15, 2027

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 3409223
  • R01DA057228 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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