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AzTrials

Cigarette Smoking-Related CarcinomaPhase 1NCT06055231

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

A Phase 1 study testing Vape device, Joint and Marijuana via vape device in people with Cigarette Smoking-Related Carcinoma, run by Roswell Park Cancer Institute.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Cigarette Smoking-Related Carcinoma
What is being tested?
Vape device, Joint and Marijuana via vape device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
15 Dec 2026to 15 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • • 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
Show all 10Show fewer
  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Danielle Smith contact

8772757724

askroswell@roswellpark.org

About this study

Official title: 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

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. Safety

PRIMARY OBJECTIVE:

  1. 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:

  1. Safety
Being tested
Vape device, Joint, Marijuana via vape device, Marijuana via joint

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vape deviceBehavioural

    Also called Behavioral Conditioning therapy, Behavioral Modification

    Consume THC via vape defice

  • JointBehavioural

    Also called Behavior Conditioning Therapy, Behavior Modification

    Consume THC via joint

  • Marijuana via vape deviceDrug

    Also called Cannibis

    Given via vape device

  • Marijuana via jointDrug

    Also called Cannibis

    Given via joint

Study groups in NCT06055231
Study groupRoleWhat they receive
Arm 1 (Vape followed by Joint)ExperimentalPatients 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.
Receives: Behavioral: Vape device; Drug: Marijuana via joint
Arm II (Joint followed by Vape)ExperimentalPatients 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.
Receives: Behavioral: Joint; Drug: Marijuana via vape device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From baseline to 360 minutes after consuming product

  2. 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.

    Measured: From baseline to 360 minutes after consuming product

  3. 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.

    Measured: From baseline to 360 minutes after consuming product

Secondary outcomes (5)

  1. Incidence of adverse events

    Number of subjects who experienced an adverse event during the study .

    Measured: Up to 360 minutes after consuming product

  2. Puffing behaviors

    Measure changes in subject puffing behavior by mean number of puffs and duration

    Measured: Through study completion, an average of 14 days

  3. 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.

    Measured: Through Study completion, an average of 14 days

  4. 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.

    Measured: Through study completion, an average of 14 days

  5. Paced Auditory Serial Addition Task (PASET)

    a validated measure used to assess attention, concentration, working memory, and information processing.

    Measured: Through study completion , an average of 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start15 Dec 2026 (estimated)
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055231
Sponsor's protocol ID
I 3409223
Other IDs
R01DA057228
Status last verified
Nov 2026
First submitted
7 Sep 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vape device, Joint and Marijuana via vape device in people with Cigarette Smoking-Related Carcinoma, run by Roswell Park Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Danielle Smith (8772757724, askroswell@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: From baseline to 360 minutes after consuming product). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06055231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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