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

Not Applicable

Recruiting

• Conditions: Cigarette Smoking-Related Carcinoma

• Registration Number: NCT07167225
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

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.

Study Timeline

• Study Start: 2025-04-03
• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Study First Posted: 2025-09-11
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-26
• Primary Completion: 2028-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in biomarker levels across groups	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 Outcome Measures

Name	Time	Method
Differences in self reported nicotine and cannabis use behaviors	1 study session (1 hour)	Self reported questionnaire
Differences in psychosocial characteristics by group	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.
Study interest	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.
Recall of study recruitment advertisement type	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.
Recall of recruitment channel	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.
Completion method chosen by participants	1 study session (1 hour)	On campus versus off-campus

Trial Locations

Locations (1)

Roswell Park Comprehensive Cancer Center; 🇺🇸 Buffalo, New York, United States