Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use Cigarettes, E-cigarettes and Cannabis (Co-Tox Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-25
SponsorRoswell Park Cancer Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Young adult (18-25 years old).
Ability to read and write in English.
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.
Disqualifiers
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 population
Young adults (18-25 year old) currently using cannabis products and/or electronic cigarettes containing nicotine.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Effectiveness of different recruitment approaches
Other interventionSubjects will asked which type of recruitment material they've seen when completing the screening survey
Choice of study completion locations
Other interventionsubjects will choose location when coordinator calls to schedule appointment
Cannabis Engagement Assessment
Other interventionSelf 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
Other interventionA 22-item questionnaire measuring e-cigarette dependence. Higher scores indicate greater dependence.
Nicotine dependence Scale
Other interventionSelf reported measure of current nicotine use that contains 27 questions assessing quantity, frequency of use in past 6 months
Co use practices QUestionnaire
Other interventionSelf reported measure of nicotine and cannabis use that contains 25 questions assessing quantity, frequency and practices of use in past 30 days
Treatment groups
150 Participants
are divided into 5 treatment groupsGroup A: E-cigarette consumers3 interventions
Group B: Cannabis consumers3 interventions
Group C: e-cigarette -cannabis coconsumers4 interventions
Group D: Cigarette coconsumers3 interventions
Group E: Cigarette-cannabis coconsumer5 interventions
Trial outcomes
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.
Time frame
1 study session lasting 1 hourSecondary outcomes
1
Differences in self reported nicotine and cannabis use behaviors
Self reported questionnaire
Time frame
1 study session (1 hour)2
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.
Time frame
1 study session (1 hour)3
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.
Time frame
Up to 1 year4
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.
Time frame
1 study session (1 hour)Sponsors and contacts
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Source ClinicalTrials.gov