Study on THC Vaping Liquids and Nicotine Use

This study is looking at how THC vaping liquids are absorbed into your bloodstream, especially when you also use nicotine vapes. Researchers want to understand how the amount of THC in your blood changes depending on whether you vape nicotine before or after THC. You may be able to join if you are at least 21 years old and have been using commercial THC vaping cartridges for at least three months, and also use nicotine vapes. The main goals are to measure the highest level of THC in your blood (Cmax) and how much THC is in your blood over time (AUC0-360) within 21 days. The study is currently unclear on its recruitment status and plans to enroll 60 participants.

Study design
This is an interventional study where participants are randomly assigned to one of three groups. It plans to enroll 60 participants.
What's involved
You would complete three vaping sessions, each separated by 7-14 days. Each session involves vaping placebo nicotine, THC, and/or active nicotine, along with blood collection and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your THC levels will be measured for up to 21 days after the vaping sessions.

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NCT06334016

Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream

Not Yet Recruiting
EARLY_PHASE1Ages 21+InterventionalBasic science
Roswell Park Cancer Institute
~60 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCannabis sativa ExtractNicotinePlacebo AdministrationQuestionnaire Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum concentration of THC in plasma (Cmax)
Measured over Up to 21 days
+2 more outcomes measured
Cannabis Dependence
1 sites across 1 states
New York1
  • Danielle M Smith · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

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Eligibility criteria

Inclusion

Age ≥ 21 years of age; (self-reported on screening, verified at study visit).
Report use of commercial THC vaping cartridges for at least 3 months prior to enrollment; (self-reported).
Experience with THC potency at or above the study product AND experience with chasing THC with nicotine (at least monthly); (self-reported).
Report use of THC vaping liquids at least weekly (4x/month); (self-reported).
Daily use of nicotine vaping products containing 5% nicotine for at least 3 months prior to enrollment; (self-reported).
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), semi-quantitative urinary THCA rapid test (NarcoCheck® THC Pre Dosage), and an illicit drug urine test (NarcoCheck® Évolutive®) during baseline testing, prior to receiving any study-related products.
Negative THC saliva test (NarcoCheck Ref#: NCE-S-THC-1), detection level 1-3 on urinary THCA rapid test (NarcoCheck® THC PreDosage), and illicit drug screen negative for all drugs except THC (NarcoCheck® Évolutive®).
Willing to abstain from nicotine use for 8 hours prior to each study session and abstain from cannabis use 7 days prior to each session.
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

Detection level 4-5 (\> 300 ng/mL) on urinary THCA rapid test (NarcoCheck® THC PreDosage Ref#: DOA-M03-9B) and a positive result on THC saliva test (NarcoCheck Ref#: NCE-S-THC-1).
Illegal or non-prescription drug use within the past 90 days. As detected by NarcoCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product. THC use detected by NarcoCheck® Évolutive® is permitted
Illegal or non-prescription drug use/alcohol substance use disorder (SUD) within the past year; (self-reported).
Report 2 or more drinking occasions/week with 4 or more drinks/occasion; (self-reported).
Report of daily cigarette use; (self-reported).
Current or prior diagnosis of schizophrenia, bipolar disorder, or other severe psychotic mental illness; (self-reported).
Current or prior diagnosis of myocardial infarction, arrhythmia, or congestive heart failure (self-reported).
Current or prior cancer diagnosis.
Pregnant, currently trying to become pregnant, or breastfeeding (females); (self-reported; pregnancy validated on study visit by urine test).
Regular use of medications that contain nicotine, induce CYP2A6, stimulants, or sympatholytics (e.g., beta-blockers); (self-reported).
Unwilling or unable to follow protocol requirements.
Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation.
The following special populations will be excluded:
Cognitively impaired adults/adults with impaired decision-making capacity
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
No children or person under the age of 21 will be involved in the study. While those under 21 may use cannabis smoked or vaping products, the legal age of purchasing and using those products in New York State is 21. The current legal age to purchase and use tobacco products in New York State (NYS) is 21. Thus, our provision of study product to adults aged 21 and older is in line with current NYS law.
  • Maximum concentration of THC in plasma (Cmax)Up to 21 days

    Pharmacokinetics (PK) profiles of THC in plasma will be determined using a visual plot of plasma THC concentrations by time. Parameters will be derived using non-compartmental analysis in Phoenix WinNonlin and adjusted for baseline THC levels. Will be summarized by nicotine status using the appropriate descriptive statistics and graphical summaries.

  • Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360)Up to 21 days

    Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models

  • Time to maximum concentration of THC in plasma (Tmax)Up to 21 days

    Blood samples will be collected for plasma levels of THC. Parameters will be derived using linear mixed models.