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.
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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 15 Sep 2027
- Phase
- Phase 1
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.
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:
- 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:
- Safety
PRIMARY OBJECTIVE:
- 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:
- Safety
- Conditions
- Cigarette Smoking-Related Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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
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
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)
Incidence of adverse events
Number of subjects who experienced an adverse event during the study .
Measured: Up to 360 minutes after consuming product
Puffing behaviors
Measure changes in subject puffing behavior by mean number of puffs and duration
Measured: Through study completion, an average of 14 days
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
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
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.
- First posted26 Sep 2023
- Study start15 Sep 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Danielle Smith, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055231
- Sponsor's protocol ID
- I 3409223
- Other IDs
- R01DA057228
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided