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Recruiting NCT07167225

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

— Observational Cigarette Smoking-Related Carcinoma E-Cig Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Effectiveness of different recruitment approaches, Choice of study completion locations, Cannabis Engagement Assessment, E-cigarette dependence Scale.
Who it may be relevant to
Registry conditions: Cigarette Smoking-Related Carcinoma, E-Cig Use. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Effectiveness of different recruitment approaches
    Subjects will asked which type of recruitment material they've seen when completing the screening survey
  • Other Choice of study completion locations
    subjects will choose location when coordinator calls to schedule appointment
  • 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.
  • Other E-cigarette dependence Scale
    A 22-item questionnaire measuring e-cigarette dependence. Higher scores indicate greater dependence.

Primary outcome measures

  • Differences in biomarker levels across groups [Time frame: 1 study session lasting 1 hour]
Secondary outcome measures (6)
  • Differences in self reported nicotine and cannabis use behaviors [Time frame: 1 study session (1 hour)]
  • Differences in psychosocial characteristics by group [Time frame: 1 study session (1 hour)]
  • Study interest [Time frame: Up to 1 year]
  • Recall of study recruitment advertisement type [Time frame: 1 study session (1 hour)]
  • Recall of recruitment channel [Time frame: 1 study session (1 hour)]
  • Completion method chosen by participants [Time frame: 1 study session (1 hour)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Roswell Park Comprehensive Cancer Center — Buffalo

Identifiers

NCT: NCT07167225 · I-4235024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗