PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis (NCT06055231) | Clinical Trial Compass
Not Yet RecruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
40 participantsStarted 2026-05-01
Plain-language 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
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how THC from vaping versus smoking cannabis gets absorbed into the bloodstream — since it's a Phase 1 study focused on drug levels rather than treating a disease, how would participating in it actually relate to managing or understanding my own cancer risk or diagnosis?
2The trial isn't recruiting yet, so there could be a significant wait before it even opens — given where I am right now in my diagnosis or treatment, is this the right time to consider a study like this, or should we focus on more immediately available options first?
3This study involves participants actually vaping and smoking cannabis as part of the research protocol — are there any concerns about how that kind of exposure could interact with any treatments I'm currently on or affect my overall health?
4Since this is a Phase 1 trial measuring things like peak THC levels and how quickly THC enters the bloodstream, what would the findings actually tell us, and would any of that information be useful to my personal care plan?
5Are there standard treatment pathways or other studies already further along in development that might be a better fit for me to explore before considering a very early-phase study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak Plasma Concentration (Cmax)
Timeframe: From baseline to 360 minutes after consuming product
2
Area under the plasma concentration time curve from 0-360 minutes ((AUC^0-360)
Timeframe: From baseline to 360 minutes after consuming product
3
Time to maximum concentration of THC in plasma (Tmax)
Timeframe: From baseline to 360 minutes after consuming product