Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- Roswell Park Cancer Institute
- Study ID
- NCT06334016
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Cannabis Dependence
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo blood collection
- Cannabis sativa Extract — DRUGVape THC
- Nicotine — DRUGVape active nicotine
- Placebo Administration — DRUGVape placebo nicotine
- Questionnaire Administration — OTHERAncillary studies
Study Details
This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.
Key Dates
- Start date
- May 15, 2026
- Status verified
- Mar 2026
- Primary completion
- Mar 1, 2028
- Completion
- Mar 1, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Arm A (placebo, THC, nicotine)Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. * VISIT 2: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. * VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. All participants also undergo blood sample collection throughout the trial.
- Experimental: Arm B (placebo, THC, nicotine)Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. * VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. * VISIT 3: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. All participants also undergo blood sample collection throughout the trial.
- Experimental: Arm C (placebo, THC, nicotine)Participants complete 3 vaping sessions separated by 7-14 days on study: * VISIT 1: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then nicotine for 10 minutes. * VISIT 2: Participants vape placebo nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine again for 10 minutes. * VISIT 3: Participants vape nicotine for 10 minutes, followed by THC for 10 minutes, and then placebo nicotine for 10 minutes. All participants also undergo blood sample collection throughout the trial.
Primary Outcome Measure
Maximum concentration of THC in plasma (Cmax) [ Time Frame: Up to 21 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Danielle M. Smith (PRINCIPAL_INVESTIGATOR) |
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