Cigarette Smoking-Related CarcinomaNCT07167225
Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use Cigarettes, E-cigarettes and Cannabis (Co-Tox Study)
An observational study of Cigarette Smoking-Related Carcinoma and E-Cig Use, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma, E-Cig Use
- What is being tested?
- Effectiveness of different recruitment approaches, Choice of study completion locations and Cannabis Engagement Assessment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults (18-25 year old) currently using cannabis products and/or electronic cigarettes containing nicotine.
Who may be able to join
- 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
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- Predominant cigarette consumers: defined as using cigarettes at least daily for the past six months, but not have used other nicotine-containing products more than weekly or cannabis products for the past month
- Predominant cigarette-cannabis co-consumers: defined as those reporting daily cigarette use and use of cannabis at least 3x/week (including smoking or vaping) for at least the past six months, with no more than weekly use of other nicotine-containing products
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
ASK RPCI, 877-275-7724
About this 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- Being tested
- Effectiveness of different recruitment approaches, Choice of study completion locations, Cannabis Engagement Assessment, E-cigarette dependence Scale, Nicotine dependence Scale
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effectiveness of different recruitment approachesOther
Subjects will asked which type of recruitment material they've seen when completing the screening survey
Choice of study completion locationsOther
subjects will choose location when coordinator calls to schedule appointment
Cannabis Engagement AssessmentOther
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 ScaleOther
A 22-item questionnaire measuring e-cigarette dependence. Higher scores indicate greater dependence.
Nicotine dependence ScaleOther
Self reported measure of current nicotine use that contains 27 questions assessing quantity, frequency of use in past 6 months
Co use practices QUestionnaireOther
Self reported measure of nicotine and cannabis use that contains 25 questions assessing quantity, frequency and practices of use in past 30 days
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette consumers | Predominant e-cigarette consumers Receives: Other: Effectiveness of different recruitment approaches; Other: Choice of study completion locations; Other: E-cigarette dependence Scale | |
| Cannabis consumers | Predominant cannabis consumers Receives: Other: Effectiveness of different recruitment approaches; Other: Choice of study completion locations; Other: Cannabis Engagement Assessment | |
| e-cigarette -cannabis coconsumers | Consumers who use both e-cigarettes and cannabis . Receives: Other: Effectiveness of different recruitment approaches; Other: Choice of study completion locations; Other: Cannabis Engagement Assessment; Other: E-cigarette dependence Scale | |
| Cigarette coconsumers | Predominant cigarette consumer Receives: Other: Effectiveness of different recruitment approaches; Other: Choice of study completion locations; Other: Nicotine dependence Scale | |
| Cigarette-cannabis coconsumer | Consumers who use both Cigarette and cannabis Receives: Other: Effectiveness of different recruitment approaches; Other: Choice of study completion locations; Other: Cannabis Engagement Assessment; Other: Nicotine dependence Scale; Other: Co use practices QUestionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 study session lasting 1 hour
Secondary outcomes (6)
Differences in self reported nicotine and cannabis use behaviors
Self reported questionnaire
Measured: 1 study session (1 hour)
Differences in psychosocial characteristics by group
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.
Measured: 1 study session (1 hour)
Study interest
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.
Measured: Up to 1 year
Recall of study recruitment advertisement type
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.
Measured: 1 study session (1 hour)
Recall of recruitment channel
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.
Measured: 1 study session (1 hour)
Completion method chosen by participants
On campus versus off-campus
Measured: 1 study session (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start3 Apr 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Smith, PhD, Principal investigator, Roswell Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167225
- Sponsor's protocol ID
- I-4235024
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use Cigarettes, E-cigarettes and Cannabis (Co-Tox Study)
- ClinicalTrials.gov ID
- NCT07167225
- Acronym / sponsor ID
- I-4235024
- Conditions
- Cigarette Smoking-Related Carcinoma, E-Cig Use
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| E-cigarette consumers | – | Other: Effectiveness of different recruitment approaches, Other: Choice of study completion locations, Other: E-cigarette dependence ScalePredominant e-cigarette consumers |
| Cannabis consumers | – | Other: Effectiveness of different recruitment approaches, Other: Choice of study completion locations, Other: Cannabis Engagement AssessmentPredominant cannabis consumers |
| e-cigarette -cannabis coconsumers | – | Other: Effectiveness of different recruitment approaches, Other: Choice of study completion locations, Other: Cannabis Engagement Assessment, Other: E-cigarette dependence ScaleConsumers who use both e-cigarettes and cannabis . |
| Cigarette coconsumers | – | Other: Effectiveness of different recruitment approaches, Other: Choice of study completion locations, Other: Nicotine dependence ScalePredominant cigarette consumer |
| Cigarette-cannabis coconsumer | – | Other: Effectiveness of different recruitment approaches, Other: Choice of study completion locations, Other: Cannabis Engagement Assessment, Other: Nicotine dependence Scale, Other: Co use practices QUestionnaireConsumers who use both Cigarette and cannabis |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults (18-25 year old) currently using cannabis products and/or electronic cigarettes containing nicotine.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effectiveness of different recruitment approachesSubjects will asked which type of recruitment material they've seen when completing the screening survey | Other | Cannabis consumers, Cigarette coconsumers, Cigarette-cannabis coconsumer, E-cigarette consumers, e-cigarette -cannabis coconsumers |
| Choice of study completion locationssubjects will choose location when coordinator calls to schedule appointment | Other | Cannabis consumers, Cigarette coconsumers, Cigarette-cannabis coconsumer, E-cigarette consumers, e-cigarette -cannabis coconsumers |
| Cannabis Engagement AssessmentSelf 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 | Cannabis consumers, Cigarette-cannabis coconsumer, e-cigarette -cannabis coconsumers |
| E-cigarette dependence ScaleA 22-item questionnaire measuring e-cigarette dependence. Higher scores indicate greater dependence. | Other | E-cigarette consumers, e-cigarette -cannabis coconsumers |
| Nicotine dependence ScaleSelf reported measure of current nicotine use that contains 27 questions assessing quantity, frequency of use in past 6 months | Other | Cigarette coconsumers, Cigarette-cannabis coconsumer |
| Co use practices QUestionnaireSelf reported measure of nicotine and cannabis use that contains 25 questions assessing quantity, frequency and practices of use in past 30 days | Other | Cigarette-cannabis coconsumer |
Primary outcome
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.
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danielle Smith, PhD principal investigator
Roswell Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking-Related Carcinoma and E-Cig Use, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASK RPCI (1-800-767-9355, askroswell@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in biomarker levels across groups (time frame: 1 study session lasting 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.