Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
NCT ID: NCT06334016
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
60 participants
INTERVENTIONAL
2026-02-15
2028-03-01
Brief Summary
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Detailed Description
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I. Assess pharmacokinetic (PK)/pharmacodynamic (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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
Biospecimen Collection
Undergo blood collection
Cannabis sativa Extract
Vape THC
Nicotine
Vape active nicotine
Placebo Administration
Vape placebo nicotine
Questionnaire Administration
Ancillary studies
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.
Biospecimen Collection
Undergo blood collection
Cannabis sativa Extract
Vape THC
Nicotine
Vape active nicotine
Placebo Administration
Vape placebo nicotine
Questionnaire Administration
Ancillary studies
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.
Biospecimen Collection
Undergo blood collection
Cannabis sativa Extract
Vape THC
Nicotine
Vape active nicotine
Placebo Administration
Vape placebo nicotine
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo blood collection
Cannabis sativa Extract
Vape THC
Nicotine
Vape active nicotine
Placebo Administration
Vape placebo nicotine
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
21 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Danielle M Smith
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Facility Contacts
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Danielle M. Smith
Role: primary
Other Identifiers
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NCI-2024-01556
Identifier Type: REGISTRY
Identifier Source: secondary_id
I-3597023
Identifier Type: OTHER
Identifier Source: secondary_id
I-3597023
Identifier Type: -
Identifier Source: org_study_id