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NCT Number: NCT07167225

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

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.

Recruiting

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

ASK RPCI

CONTACT

877-275-7724

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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 informed consent form before proceeding with study activities.

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

Treatment and study plan

Effectiveness of different recruitment approaches

Other

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

Choice of study completion locations

Other

subjects will choose location when coordinator calls to schedule appointment

Cannabis Engagement Assessment

Other

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.

E-cigarette dependence Scale

Other

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

Primary outcomes

  1. Differences in biomarker levels across groups

    Time frame: 1 study session lasting 1 hour

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

Secondary outcomes

  1. Differences in self reported nicotine and cannabis use behaviors

    Time frame: 1 study session (1 hour)

    Self reported questionnaire

  2. Differences in psychosocial characteristics by group

    Time frame: 1 study session (1 hour)

    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.

  3. Study interest

    Time frame: Up to 1 year

    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.

  4. Recall of study recruitment advertisement type

    Time frame: 1 study session (1 hour)

    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.

  5. Recall of recruitment channel

    Time frame: 1 study session (1 hour)

    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.

  6. Completion method chosen by participants

    Time frame: 1 study session (1 hour)

    On campus versus off-campus

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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