Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use E-cigarettes and Cannabis (Co-Tox Study)
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2025
CompletedFirst Submitted
Initial submission to the registry
August 27, 2025
CompletedFirst Posted
Study publicly available on registry
September 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
October 3, 2025
September 1, 2025
3.4 years
August 27, 2025
September 29, 2025
Conditions
Outcome Measures
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.
1 study session lasting 1 hour
Secondary Outcomes (6)
Differences in self reported nicotine and cannabis use behaviors
1 study session (1 hour)
Differences in psychosocial characteristics by group
1 study session (1 hour)
Study interest
Up to 1 year
Recall of study recruitment advertisement type
1 study session (1 hour)
Recall of recruitment channel
1 study session (1 hour)
- +1 more secondary outcomes
Study Arms (3)
E-cigarette consumers
Predominant e-cigarette consumers
Cannabis consumers
Predominant cannabis consumers
e-cigarette -cannabis coconsumers
Consumers who use both e-cigarettes and cannabis .
Interventions
Subjects will asked which type of recruitment material they've seen when completing the screening survey
subjects will choose location when coordinator calls to schedule appointment
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.
A 22-item questionnaire measuring e-cigarette dependence. Higher scores indicate greater dependence.
Eligibility Criteria
Young adults (18-25 year old) currently using cannabis products and/or electronic cigarettes containing nicotine.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Smith, PhD
Roswell Park
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2025
First Posted
September 11, 2025
Study Start
April 3, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
October 3, 2025
Record last verified: 2025-09