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RecruitingNCT07167225Updated Aug 26, 2026

Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use Cigarettes, E-cigarettes and Cannabis (Co-Tox Study)

An observational study in Cigarette Smoking-Related Carcinoma and E-Cig Use, sponsored by Roswell Park Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Roswell Park Cancer Institute · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 25 Years
Sex
All
01

Study summary

This study evaluates the amount of nicotine, cannabis, and toxicants linked to the use of nicotine e-cigarette and/or cannabis products in the blood and urine of young adult users as well as the cannabis and nicotine use behaviors of consumers.

Read the detailed description

PRIMARY OBJECTIVE:

I. To evaluate differences in self-reported nicotine and cannabis use behaviors and biomarkers of exposure to toxicants and carcinogens by product use status, to generate effect sizes required to calculate sample sizes needed for a larger study.

02

Conditions studied

  • Cigarette Smoking-Related Carcinoma
  • E-Cig Use

Browse trials for

03

In context

Vaping

402 studies on the registry are indexed under Vaping; 95 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 65 observational studies indexed under Vaping.

Browse Vaping studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Young adults (18-25 year old) currently using cannabis products and/or electronic cigarettes containing nicotine.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Young adult (18-25 years old).
  • Ability to read and write in English.
  • Participants must fall into one of the following groups (based on self-report):
  • Predominant e-cigarette consumer: defined as using nicotine-containing e-cigarettes daily for the past six months but not having used other nicotine containing products more than weekly or cannabis products for the past month.
  • Predominant cannabis consumer: defined as using cannabis at least 3x/week for the past six months in any form, including smoking, vaping, and oral use, with no more than weekly use of any nicotine or tobacco products.
  • E-cigarette-cannabis co-consumers: defined as daily use of nicotine e-cigarettes and use of cannabis at least 3x/week, including smoking, vaping, and oral use, for at least the past six months, with no use of other nicotine containing products more than weekly
  • Predominant cigarette consumers: defined as using cigarettes at least daily for the past six months, but not have used other nicotine-containing products more than weekly or cannabis products for the past month
  • Predominant cigarette-cannabis co-consumers: defined as those reporting daily cigarette use and use of cannabis at least 3x/week (including smoking or vaping) for at least the past six months, with no more than weekly use of other nicotine-containing products
  • No self-reported diagnosis of kidney disease (current, or within the past year prior to the study visit).
  • Participants must understand the voluntary nature of this study and sign a written form before proceeding with study activities.

Exclusion criteria

Exclusion Criteria:

  • Individuals under the age of 18 or over the age of 25.
  • Currently pregnant or breastfeeding (female participants).
  • Unwilling or unable to follow protocol requirements
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • E-cigarette consumers

    Predominant e-cigarette consumers

    Other: Effectiveness of different recruitment approaches · Other: Choice of study completion locations · Other: E-cigarette dependence Scale

  • Cannabis consumers

    Predominant cannabis consumers

    Other: Effectiveness of different recruitment approaches · Other: Choice of study completion locations · Other: Cannabis Engagement Assessment

  • e-cigarette -cannabis coconsumers

    Consumers who use both e-cigarettes and cannabis .

    Other: Effectiveness of different recruitment approaches · Other: Choice of study completion locations · Other: Cannabis Engagement Assessment · Other: E-cigarette dependence Scale

  • Cigarette coconsumers

    Predominant cigarette consumer

    Other: Effectiveness of different recruitment approaches · Other: Choice of study completion locations · Other: Nicotine dependence Scale

  • Cigarette-cannabis coconsumer

    Consumers who use both Cigarette and cannabis

    Other: Effectiveness of different recruitment approaches · Other: Choice of study completion locations · Other: Cannabis Engagement Assessment · Other: Nicotine dependence Scale · Other: Co use practices QUestionnaire

Interventions

  • OtherEffectiveness of different recruitment approaches

    Subjects will asked which type of recruitment material they've seen when completing the screening survey

  • OtherChoice of study completion locations

    subjects will choose location when coordinator calls to schedule appointment

  • OtherCannabis Engagement Assessment

    Self reported measure of current cannabis use that contains 30 questions assessing quantity, frequency of use and method of consumption in the past 30 days.

  • OtherE-cigarette dependence Scale

    A 22-item questionnaire measuring e-cigarette dependence. Higher scores indicate greater dependence.

  • OtherNicotine dependence Scale

    Self reported measure of current nicotine use that contains 27 questions assessing quantity, frequency of use in past 6 months

  • OtherCo use practices QUestionnaire

    Self reported measure of nicotine and cannabis use that contains 25 questions assessing quantity, frequency and practices of use in past 30 days

06

What researchers measure

Primary outcomes

  1. Differences in biomarker levels across groups

    Will compare the mean biomarker levels between groups using a one-way ANOVA model, with Bonferroni-adjusted pairwise comparisons, as appropriate.

    Time frame: 1 study session lasting 1 hour

Secondary outcomes

  1. Differences in self reported nicotine and cannabis use behaviors

    Self reported questionnaire

    Time frame: 1 study session (1 hour)

  2. Differences in psychosocial characteristics by group

    Will be compared between groups using the appropriate general linear models. All model and test assumptions will be verified graphically, with transformations applied as appropriate.

    Time frame: 1 study session (1 hour)

  3. Study interest

    Study interest and eligibility Measured via number of contacts to inquire about the study, and number of eligible applicants. The eligibility and interest rates of the individuals approached and the completion rates of the enrolled individuals will be estimated overall and by relevant factors (recruitment channel, type of advertisement) using 90% credible regions obtained by Jeffrey's prior method.

    Time frame: Up to 1 year

  4. Recall of study recruitment advertisement type

    Analyses will be primarily descriptive to evaluate the reach and effectiveness of recruitment strategies. Key endpoints will be summarized overall and by relevant factors (ex., recruitment channel) using the appropriate descriptive statistics, with comparisons made using the Mann-Whitney U and Kruskal Wallis or Fisher's exact and Pearson chi-square tests, as appropriate.

    Time frame: 1 study session (1 hour)

  5. Recall of recruitment channel

    Will include where study information/advertisement was viewed. Analyses will be primarily descriptive to evaluate the reach and effectiveness of recruitment strategies. Key endpoints will be summarized overall and by relevant factors ex., recruitment channel) using the appropriate descriptive statistics.

    Time frame: 1 study session (1 hour)

  6. Completion method chosen by participants

    On campus versus off-campus

    Time frame: 1 study session (1 hour)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2025 (actual). Primary completion is estimated for Oct 2028, 41 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2025
First posted
Sep 11, 2025
StartActual
Apr 3, 2025
Primary completionEst.
Oct 1, 2028
CompletionEst.
Oct 1, 2028
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07167225
Responsible party
Sponsor
First posted
Sep 11, 2025
Start date
Apr 3, 2025
Primary completion
Oct 1, 2028 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Aug 26, 2026

Study contacts

ASK RPCI
Contact
askroswell@roswellpark.org
1-800-767-9355
Danielle Smith, PhD
principal investigator · Roswell Park

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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