Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334016
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-07
Brief Title:
Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Acute Effects of Sequential Nicotine Vaping on the Pharmacokinetic and Pharmacodynamic Properties of Vaped THC A Double-Blind Placebo-Controlled Randomized Within-Subject Crossover Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PRIMARY OBJECTIVES
I Assess pharmacokinetic PKpharmacodynamic PD profiles of THC vaping liquids administered with co-use of vaped nicotine
II Outcomes of interest will be assessed overall and according to biological sex
SECONDARY OBJECTIVES
I Safety II Assessment of differences in puffing behaviors III Short-term subjective drug effects and cognitive performance following THC use without nicotine versus vs THC use with pre-nicotine use vs THC use with post-nicotine use in current consumers of both vaped cannabis and vaped nicotine products
OUTLINE Participants are randomized to 1 of 3 arms
ARM A 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
ARM B 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
ARM C 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
After completion of study intervention participants are followed up at 30 days
I Assess pharmacokinetic PKpharmacodynamic PD profiles of THC vaping liquids administered with co-use of vaped nicotine
II Outcomes of interest will be assessed overall and according to biological sex
SECONDARY OBJECTIVES
I Safety II Assessment of differences in puffing behaviors III Short-term subjective drug effects and cognitive performance following THC use without nicotine versus vs THC use with pre-nicotine use vs THC use with post-nicotine use in current consumers of both vaped cannabis and vaped nicotine products
OUTLINE Participants are randomized to 1 of 3 arms
ARM A 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
ARM B 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
ARM C 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
After completion of study intervention participants are followed up at 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01556 | REGISTRY | None | None |
| I-3597023 | OTHER | None | None |
| R01DA057228 | NIH | Roswell Park Cancer Institute | httpsreporternihgovquickSearchR01DA057228 |