AzTrials
AzTrials

Cannabis DependenceEarly Phase 1NCT06334016

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

A Early Phase 1 study testing Biospecimen Collection, Cannabis sativa Extract and Nicotine in people with Cannabis Dependence, run by Roswell Park Cancer Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Cannabis Dependence
What is being tested?
Biospecimen Collection, Cannabis sativa Extract and Nicotine
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
15 Oct 2026to 1 Mar 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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).
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Danielle M. Smith, 716-845-8403, Danielle.Smith@RoswellPark.org

    Danielle M. Smith

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Cannabis sativa Extract, Nicotine, Placebo Administration, Questionnaire Administration
Medical subject headings
Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood collection

  • Cannabis sativa ExtractDrug

    Also called Cannabis sativa, Cannabis sativa Flowering Top, Cannabis sativa Subsp. Flowering Top Extract, Cannabis sativa Top

    Vape THC

  • NicotineDrug

    Also called (-)-Nicotine, NIC

    Vape active nicotine

  • Placebo AdministrationDrug

    Vape placebo nicotine

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06334016
Study groupRoleWhat they receive
Arm A (placebo, THC, nicotine)ExperimentalParticipants 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.
Receives: Procedure: Biospecimen Collection; Drug: Cannabis sativa Extract; Drug: Nicotine; Drug: Placebo Administration; Other: Questionnaire Administration
Arm B (placebo, THC, nicotine)ExperimentalParticipants 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.
Receives: Procedure: Biospecimen Collection; Drug: Cannabis sativa Extract; Drug: Nicotine; Drug: Placebo Administration; Other: Questionnaire Administration
Arm C (placebo, THC, nicotine)ExperimentalParticipants 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.
Receives: Procedure: Biospecimen Collection; Drug: Cannabis sativa Extract; Drug: Nicotine; Drug: Placebo Administration; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum concentration of THC in plasma (Cmax)

    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.

    Measured: Up to 21 days

  2. Area under the plasma concentration-time curve from 0-360 minutes (AUC0-360)

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

    Measured: Up to 21 days

  3. Time to maximum concentration of THC in plasma (Tmax)

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

    Measured: Up to 21 days

Secondary outcomes (8)

  1. Incidence of adverse events (AEs)

    AEs will be summarized by nicotine condition and grade using frequencies and relative frequencies. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.

    Measured: Up to 30 days after completion of study intervention

  2. Puffing behaviors

    puff duration

    Measured: Up to 21 days

  3. Puffing behaviors

    puff number

    Measured: Up to 21 days

  4. Short-term drug effects

    The short-term drug effects (Drug Effects Questionnaire [DEQ), The DEQ rates sixteen component items using a visual analog scale (0-100) to examine drug effects pre- and post-use

    Measured: Up to 21 days

  5. Marijuana Withdrawal Checklist [MWC)

    The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from "0" = no withdrawal symptoms to "47" = maximally high levels of withdrawal

    Measured: Up to 21 days

  6. Digit Symbol Substitution Task (DSST)

    An assessment of cognitive dysfunction that test ability to complete daily tasks

    Measured: Up to 21 days

  7. Paced Auditory Serial Addition Task (PASET)

    Measures of working memory and concentration .

    Measured: Up to 21 days

  8. Tobacco Craving Questionnaire (Short Form)

    Self reported 47-item questionnaire that assesses tobacco craving. Items are rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). Factor scores for each participant are obtained by summing the three items in each factor scale, yielding a score ranging from 3 to 21.

    Measured: Up to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Within-subject crossover study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06334016
Sponsor's protocol ID
I-3597023
Other IDs
NCI-2024-01556, I-3597023, R01DA057228
Status last verified
Sep 2026
First submitted
7 Mar 2024
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biospecimen Collection, Cannabis sativa Extract and Nicotine in people with Cannabis Dependence, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum concentration of THC in plasma (Cmax) (time frame: Up to 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06334016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in