Tobacco Use BehaviorNCT07910331
§SMOKE Nicotine and Tobacco Youth Cohort
An observational study of Tobacco Use Behavior and Nicotine Dependence Tobacco Product, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The §SMOKE Cohort Study aims to improve understanding of tobacco and nicotine use among adolescents and young adults in Denmark. The study focuses on a rapidly changing nicotine landscape that includes cigarettes, e-cigarettes, nicotine pouches, heated tobacco products, and other nicotine products. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Tobacco Use Behavior, Nicotine Dependence Tobacco Product, E-Cigarette Use
- How many people
- 10,000 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Sep 2026to 1 Jul 2031
- 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 15 to 25 years
- All sexes
- Child, Adult
Study population: The study population consists of adolescents and young adults residing in Denmark who participate in the 2026 §SMOKE survey. Participants are recruited from a national population-based sample identified through the Danish Civil Registration System and invited through the Danish digital postal system (e-Boks). The cohort includes individuals aged 15-25 years at baseline and is intended to be broadly representative of young people living in Denmark. The study population encompasses individuals with varying tobacco and nicotine use patterns, including non-users, experimental users, current users, former users, and users of different tobacco and nicotine products such as cigarettes, e-cigarettes, nicotine pouches, and heated tobacco products.
Who may be able to join
- Aged 15 to 25 years at the time of baseline
- Resident in Denmark
- Participated in the 2026 §SMOKE survey
Who cannot join
- Not resident in Denmark at the time of baseline survey participation
- Younger than 15 years or older than 25 years at baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lotus Sofie Bast, Senior researcher contact
Denmark1 site, 1 recruiting
- Recruiting
The National Institute of Public Health
Copenhagen, 2400
Lisbeth Lund, Postdoc, 004523902724, lilu@sdu.dk
Lotus Sofie Bast, Senior researcher, loni@sdu.dk
About this study
Official title: The §SMOKE Cohort Study: a National Longitudinal Cohort of Tobacco and Nicotine Use Among Danish Adolescents and Young Adults.
The §SMOKE Cohort Study aims to improve understanding of tobacco and nicotine use among adolescents and young adults in Denmark. The study focuses on a rapidly changing nicotine landscape that includes cigarettes, e-cigarettes, nicotine pouches, heated tobacco products, and other nicotine products.
The study is based on the hypothesis that tobacco and nicotine use during adolescence and young adulthood follows different developmental pathways and that individual characteristics, social influences, and environmental factors affect initiation, continued use, cessation, relapse, and switching between products. The study further hypothesizes that different patterns of tobacco and nicotine use are associated with differences in educational, health, and social outcomes.
By following young people over time, the study seeks to improve understanding of how tobacco and nicotine use develops, which factors influence these behaviors, and what consequences may be associated with different patterns of use. The findings will contribute to evidence supporting tobacco and nicotine prevention efforts and public health policy for adolescents and young adults in Denmark.
Read the detailed description
The §SMOKE Cohort Study is a national prospective longitudinal cohort study established to generate evidence on the development, determinants, and consequences of tobacco and nicotine use among adolescents and young adults in Denmark. The study was initiated in response to substantial changes in the tobacco and nicotine market, including the increasing availability and use of electronic cigarettes, nicotine pouches, heated tobacco products, disposable vaping products, and other emerging nicotine products. While surveillance systems provide important information on prevalence and trends in population-level tobacco and nicotine use, there is limited evidence on how the use of different products develops over time within individuals, the factors that influence transitions between products, and the longer-term consequences associated with different patterns of use.
The primary objective of the study is to establish a national cohort of Danish adolescents and young adults and follow participants over time in order to characterize trajectories and transitions in tobacco and nicotine use. The study aims to examine patterns of initiation, escalation, cessation, relapse, product switching, and multiple-product use, as well as to identify individual, psychological, interpersonal, and societal factors associated with these processes.
Participants will be recruited from the national §SMOKE survey conducted in Denmark in 2026. Approximately 10,000 individuals aged 15-25 years are expected to be enrolled and followed through annual data collections over a four-year period. Data collection consists of repeated questionnaire-based assessments designed to monitor tobacco and nicotine use behaviors, attitudes, perceptions, and related determinants. To ensure longitudinal comparability, a core set of measures will be retained across all follow-up waves. At the same time, selected questionnaire modules may be adapted during the study period to capture emerging tobacco and nicotine products, new patterns of use, changes in marketing practices, and developments in the regulatory environment.
The study is informed by a socioecological framework that recognizes tobacco and nicotine use as the result of interactions between factors operating at multiple levels. Survey measures therefore encompass tobacco and nicotine use behaviors as well as individual-level factors, including motivation for use, dependence, risk perceptions, mental health, well-being, and use of other substances; interpersonal factors, including family and peer influences; and societal factors, including exposure to tobacco and nicotine marketing, product availability, awareness of tobacco control measures, and perceptions of regulatory enforcement.
A key feature of the cohort is linkage of survey data to nationwide Danish administrative registers using the unique personal identification number assigned to all Danish residents. Register linkage enables prospective assessment of educational, health, labor market, demographic, and socioeconomic outcomes. Through these linkages, the study will examine the broader consequences of tobacco and nicotine use trajectories during adolescence and young adulthood.
Analyses will focus on understanding how tobacco and nicotine use evolves over time and identifying factors associated with transitions between use states and products. Longitudinal analytical approaches will be applied to examine developmental trajectories, transitions between patterns of use, and predictors of initiation, continuation, cessation, relapse, and product switching. Additional analyses will evaluate educational, health, social, and economic consequences associated with different patterns of tobacco and nicotine use. The study is intended to provide evidence that can support tobacco and nicotine prevention initiatives, inform regulatory decision-making, and strengthen the evidence base for public health policy targeting adolescents and young adults.
To support data quality and cohort retention, standardized data collection procedures will be used across study waves, and participant follow-up will include reminder procedures and retention activities. Analyses will incorporate appropriate methods to account for survey design, non-response, attrition, and missing data. Findings will be reported in accordance with relevant methodological and reporting standards for longitudinal observational research.
- Conditions
- Tobacco Use Behavior, Nicotine Dependence Tobacco Product, E-Cigarette Use, Smoking ( Cigarette), Smoking Cessation, Nicotine Pouches
- Keywords
- Tobacco and nicotine trajectories, Longitudinal cohort study, Register-Based Research, Tobacco use, Nicotine use, Adolescents, Young adults, Denmark
- Medical subject headings
- Tobacco Use Disorder, Vaping, Cigarette Smoking, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The §SMOKE Cohort Study | Tobacco and nicotine use behavior among young people (aged 15-25 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal tobacco and nicotine use trajectories
Patterns of tobacco and nicotine use over time, including initiation, cessation, relapse, product switching, exclusive product use, and multiple-product use.
Measured: Baseline through 4 years
Transitions between tobacco and nicotine use states/behavior
Transitions between predefined or latent use states (e.g., non-use, experimentation, regular use, cessation, relapse, and multiple-product use) observed across follow-up waves.
Measured: Baseline through 4 years
Educational, health, and social outcomes associated with tobacco and nicotine use trajectories
Educational attainment, healthcare utilization, mental health indicators, and labour market outcomes associated with different tobacco and nicotine use trajectories.
Measured: Baseline through end of available register follow-up
Predictors of tobacco and nicotine use initiation and continuation
Associations between individual, psychological, interpersonal, and societal factors and subsequent initiation, continuation, cessation, relapse, and product switching of tobacco and nicotine products. Factors include dependence symptoms, risk perceptions, mental health, peer and parental use, marketing exposure, product availability, and exposure to tobacco control policies.
Measured: Baseline through 4 years
Secondary outcomes (6)
Initiation of tobacco or nicotine product use
First reported use of any tobacco or nicotine product among baseline non-users.
Measured: Baseline through 4 years
Cessation of tobacco or nicotine use
Transition from current use to sustained non-use of tobacco or nicotine products.
Measured: Baseline through 4 years
Poly-product tobacco and nicotine use
Concurrent use of two or more tobacco or nicotine products.
Measured: Baseline through 4 years
Nicotine dependence
Level of self-reported nicotine dependence measured using survey-based indicators of dependence symptoms.
Measured: Baseline through 4 years
Perceived harm and risk perceptions
Changes in perceptions of health risks associated with tobacco and nicotine products
Measured: Baseline through 4 years
Health-related quality of life (QALYs)
Health-related quality of life associated with different tobacco and nicotine use trajectories and transition patterns, assessed using validated instruments suitable for adolescents and young adults (e.g., EQ-5D-Y and CHU9D). Quality-adjusted life years (QALYs) may be estimated directly from participant-reported data or derived using published utility weights where appropriate.
Measured: Baseline through 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start23 Sep 2026
- Primary completion15 Dec 2030 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use BehaviorStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisbeth Lund, Postdoc, Principal investigator, The National Institute of Public Health, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910331
- Sponsor's protocol ID
- 3110937
- Other IDs
- 202769, REC725
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes sensitive personal data and linked administrative register data that are subject to Danish data protection regulations and data access restrictions. Researchers may be able to apply for access to relevant data through the appropriate Danish authorities and data custodians, subject to required approvals.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The §SMOKE Cohort Study: a National Longitudinal Cohort of Tobacco and Nicotine Use Among Danish Adolescents and Young Adults.
- ClinicalTrials.gov ID
- NCT07910331
- Acronym / sponsor ID
- 3110937
- Conditions
- Tobacco Use Behavior, Nicotine Dependence Tobacco Product, E-Cigarette Use, Smoking ( Cigarette), Smoking Cessation, Nicotine Pouches
- Keywords
- Tobacco and nicotine trajectories, Longitudinal cohort study, Register-Based Research, Tobacco use, Nicotine use, Adolescents, Young adults, Denmark
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 2 Nov 2026 (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.
The §SMOKE Cohort Study aims to improve understanding of tobacco and nicotine use among adolescents and young adults in Denmark. The study focuses on a rapidly changing nicotine landscape that includes cigarettes, e-cigarettes, nicotine pouches, heated tobacco products, and other nicotine products.
The study is based on the hypothesis that tobacco and nicotine use during adolescence and young adulthood follows different developmental pathways and that individual characteristics, social influences, and environmental factors affect initiation, continued use, cessation, relapse, and switching between products. The study further hypothesizes that different patterns of tobacco and nicotine use are associated with differences in educational, health, and social outcomes.
By following young people over time, the study seeks to improve understanding of how tobacco and nicotine use develops, which factors influence these behaviors, and what consequences may be associated with different patterns of use. The findings will contribute to evidence supporting tobacco and nicotine prevention efforts and public health policy for adolescents and young adults in Denmark.
Detailed description
The §SMOKE Cohort Study is a national prospective longitudinal cohort study established to generate evidence on the development, determinants, and consequences of tobacco and nicotine use among adolescents and young adults in Denmark. The study was initiated in response to substantial changes in the tobacco and nicotine market, including the increasing availability and use of electronic cigarettes, nicotine pouches, heated tobacco products, disposable vaping products, and other emerging nicotine products. While surveillance systems provide important information on prevalence and trends in population-level tobacco and nicotine use, there is limited evidence on how the use of different products develops over time within individuals, the factors that influence transitions between products, and the longer-term consequences associated with different patterns of use.
The primary objective of the study is to establish a national cohort of Danish adolescents and young adults and follow participants over time in order to characterize trajectories and transitions in tobacco and nicotine use. The study aims to examine patterns of initiation, escalation, cessation, relapse, product switching, and multiple-product use, as well as to identify individual, psychological, interpersonal, and societal factors associated with these processes.
Participants will be recruited from the national §SMOKE survey conducted in Denmark in 2026. Approximately 10,000 individuals aged 15-25 years are expected to be enrolled and followed through annual data collections over a four-year period. Data collection consists of repeated questionnaire-based assessments designed to monitor tobacco and nicotine use behaviors, attitudes, perceptions, and related determinants. To ensure longitudinal comparability, a core set of measures will be retained across all follow-up waves. At the same time, selected questionnaire modules may be adapted during the study period to capture emerging tobacco and nicotine products, new patterns of use, changes in marketing practices, and developments in the regulatory environment.
The study is informed by a socioecological framework that recognizes tobacco and nicotine use as the result of interactions between factors operating at multiple levels. Survey measures therefore encompass tobacco and nicotine use behaviors as well as individual-level factors, including motivation for use, dependence, risk perceptions, mental health, well-being, and use of other substances; interpersonal factors, including family and peer influences; and societal factors, including exposure to tobacco and nicotine marketing, product availability, awareness of tobacco control measures, and perceptions of regulatory enforcement.
A key feature of the cohort is linkage of survey data to nationwide Danish administrative registers using the unique personal identification number assigned to all Danish residents. Register linkage enables prospective assessment of educational, health, labor market, demographic, and socioeconomic outcomes. Through these linkages, the study will examine the broader consequences of tobacco and nicotine use trajectories during adolescence and young adulthood.
Analyses will focus on understanding how tobacco and nicotine use evolves over time and identifying factors associated with transitions between use states and products. Longitudinal analytical approaches will be applied to examine developmental trajectories, transitions between patterns of use, and predictors of initiation, continuation, cessation, relapse, and product switching. Additional analyses will evaluate educational, health, social, and economic consequences associated with different patterns of tobacco and nicotine use. The study is intended to provide evidence that can support tobacco and nicotine prevention initiatives, inform regulatory decision-making, and strengthen the evidence base for public health policy targeting adolescents and young adults.
To support data quality and cohort retention, standardized data collection procedures will be used across study waves, and participant follow-up will include reminder procedures and retention activities. Analyses will incorporate appropriate methods to account for survey design, non-response, attrition, and missing data. Findings will be reported in accordance with relevant methodological and reporting standards for longitudinal observational research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The §SMOKE Cohort Study | – | –Tobacco and nicotine use behavior among young people (aged 15-25 years) |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The study population consists of adolescents and young adults residing in Denmark who participate in the 2026 §SMOKE survey. Participants are recruited from a national population-based sample identified through the Danish Civil Registration System and invited through the Danish digital postal system (e-Boks). The cohort includes individuals aged 15-25 years at baseline and is intended to be broadly representative of young people living in Denmark. The study population encompasses individuals with varying tobacco and nicotine use patterns, including non-users, experimental users, current users, former users, and users of different tobacco and nicotine products such as cigarettes, e-cigarettes, nicotine pouches, and heated tobacco products.
Key inclusion criteria (3 listed)
- Aged 15 to 25 years at the time of baseline
- Resident in Denmark
- Participated in the 2026 §SMOKE survey
Key exclusion criteria (2 listed)
- Not resident in Denmark at the time of baseline survey participation
- Younger than 15 years or older than 25 years at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Longitudinal tobacco and nicotine use trajectories
Time frame: Baseline through 4 years
Patterns of tobacco and nicotine use over time, including initiation, cessation, relapse, product switching, exclusive product use, and multiple-product use.
Transitions between tobacco and nicotine use states/behavior
Time frame: Baseline through 4 years
Transitions between predefined or latent use states (e.g., non-use, experimentation, regular use, cessation, relapse, and multiple-product use) observed across follow-up waves.
Educational, health, and social outcomes associated with tobacco and nicotine use trajectories
Time frame: Baseline through end of available register follow-up
Educational attainment, healthcare utilization, mental health indicators, and labour market outcomes associated with different tobacco and nicotine use trajectories.
Predictors of tobacco and nicotine use initiation and continuation
Time frame: Baseline through 4 years
Associations between individual, psychological, interpersonal, and societal factors and subsequent initiation, continuation, cessation, relapse, and product switching of tobacco and nicotine products. Factors include dependence symptoms, risk perceptions, mental health, peer and parental use, marketing exposure, product availability, and exposure to tobacco control policies.
6 secondary outcomes
Initiation of tobacco or nicotine product use
Time frame: Baseline through 4 years
Cessation of tobacco or nicotine use
Time frame: Baseline through 4 years
Poly-product tobacco and nicotine use
Time frame: Baseline through 4 years
Nicotine dependence
Time frame: Baseline through 4 years
Perceived harm and risk perceptions
Time frame: Baseline through 4 years
Health-related quality of life (QALYs)
Time frame: Baseline through 4 years
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 2 Nov 2026.
- WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes sensitive personal data and linked administrative register data that are subject to Danish data protection regulations and data access restrictions. Researchers may be able to apply for access to relevant data through the appropriate Danish authorities and data custodians, subject to required approvals.
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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.
Lotus Sofie Bast, Senior researcher contact
Lisbeth Lund, Postdoc principal investigator
The National Institute of Public Health, University of Southern Denmark
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 Tobacco Use Behavior and Nicotine Dependence Tobacco Product, run by University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 2 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 2 Nov 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 Denmark. 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 Lisbeth Lund, Postdoc (004523902724, lilu@sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal tobacco and nicotine use trajectories (time frame: Baseline through 4 years). The study lists 4 primary outcomes in all. 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 2 Nov 2026.