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

NCT ID: NCT07167225

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2028-09-01

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.

Conditions

Cigarette Smoking-Related Carcinoma; E-Cig Use

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

E-cigarette consumers

Predominant e-cigarette consumers

Effectiveness of different recruitment approaches

Intervention Type: OTHER

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

Choice of study completion locations

Intervention Type: OTHER

subjects will choose location when coordinator calls to schedule appointment

E-cigarette dependence Scale

Intervention Type: OTHER

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

Cannabis consumers

Predominant cannabis consumers

Effectiveness of different recruitment approaches

Intervention Type: OTHER

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

Choice of study completion locations

Intervention Type: OTHER

subjects will choose location when coordinator calls to schedule appointment

Cannabis Engagement Assessment

Intervention Type: 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 -cannabis coconsumers

Consumers who use both e-cigarettes and cannabis .

Effectiveness of different recruitment approaches

Intervention Type: OTHER

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

Choice of study completion locations

Intervention Type: OTHER

subjects will choose location when coordinator calls to schedule appointment

Cannabis Engagement Assessment

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Effectiveness of different recruitment approaches

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

Intervention Type: OTHER

Choice of study completion locations

subjects will choose location when coordinator calls to schedule appointment

Intervention Type: OTHER

Cannabis 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.

Intervention Type: OTHER

E-cigarette dependence Scale

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park

Locations

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

ASK RPCI

Role: CONTACT

askroswell@roswellpark.org

1-800-767-9355

Facility Contacts

ASK RPCI

Role: primary

877-275-7724

Other Identifiers

I-4235024

Identifier Type: -

Identifier Source: org_study_id