Who and how is using novel nicotine and tobacco products in Sweden? A follow-up study of young adults (UNIKA study)
| ISRCTN | ISRCTN16921401 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16921401 |
| Sponsor | Karolinska Institutet |
| Funder | Forskningsrådet för hälsa, arbetsliv och välfärd |
- Submission date
- 30/07/2026
- Registration date
- 08/09/2026
- Last edited
- 08/09/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The use of non-combustible nicotine and tobacco products, particularly e-cigarettes and nicotine pouches, has increased rapidly among young people in Sweden. However, there is limited information about why young people use these products, how patterns of use change over time and the potential effects on health.
This study aims to investigate the use of non-combustible nicotine and tobacco products among young people in Sweden. Researchers will examine patterns of use, reasons for starting or stopping use, social and lifestyle factors associated with use, and levels of nicotine exposure.
Who can participate?
Young people aged 16 to 29 years who live in Sweden, can read and write Swedish, and are willing to provide informed consent to take part in the study.
What does the study involve?
At least 2,500 participants will be recruited from across Sweden.
Participants will complete a questionnaire at the start of the study and a follow-up questionnaire approximately one year later.
Researchers will collect information on:
Use of nicotine and tobacco products such as e-cigarettes and nicotine pouches
Reasons for starting, continuing or stopping use
Social and lifestyle factors that may influence use
Health and healthcare use
The study will also use information from registers and laboratory measurements. Some participants will provide saliva samples to measure nicotine exposure. Participants may also be asked whether they are willing to take part in future studies involving clinical health assessments.
What are the possible benefits and risks of participating?
Participants are unlikely to receive any direct benefit from taking part. However, the findings may improve understanding of nicotine and tobacco product use among young people and help inform future public health policies and prevention strategies.
The risks associated with participation are expected to be minimal and mainly relate to the time required to complete questionnaires and provide saliva samples.
Where is the study run from?
Karolinska Institutet and collaborating centres in Sweden.
When is the study starting and how long is it expected to run for?
September 2026 to December 2028.
Who is funding the study?
Swedish Research Council for Health, Working Life and Welfare (FORTE), Sweden.
Who is the main contact?
Professor Maria Rosaria Galanti, rosaria.galanti@ki.se.
Contact information
Principal investigator, Scientific
Department of Global Public Health, Karolinska Institutet
Tomtebodavägen 18A
Stockholm
17165
Sweden
| 0000-0002-7805-280X | |
| Phone | +46 70 254 12 86 |
| rosaria.galanti@ki.se |
Public
Department of Global Public Health, Karolinska Institutet
Tomtebodavägen 18A
Stockholm
17165
Sweden
| Phone | +46 70 254 12 86 |
|---|---|
| erik.harald.anund@ki.se |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Longitudinal study |
| Scientific title | Use of non-combustible nicotine and tobacco products among young adults in Sweden. A longitudinal study on behavioral patterns, motivation to use and nicotine exposure (UNIKA study) |
| Study acronym | UNIKA |
| Study objectives | The study aims to clarify: 1. Behavioral patterns (initiation, escalation, quitting, substitution) of non-combustible nicotine or tobacco products (NC NT) use in a national sample of youths 2. Motives for initial NC NT use, continuation or discontinuation, including social influences 3. Socio-demographic and psycho-social (e.g., perceived health,health care use, social network) predictors of use and of discontinuation of NC NT 4. The estimated dose of nicotine corresponding to different individual profiles of NC NT use |
| Ethics approval(s) |
Approved 08/06/2026, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, Uppsala, 750 02, Sweden; +46 10 4750800; registrator@etikprovning.se), ref: 2026-03526-01 |
| Health condition(s) or problem(s) studied | Use of non-combustible nicotine and tobacco products (NCNT) |
| Methodology | This is a population-based longitudinal study with a baseline assessment and one follow-up point. It aims to enroll a sample of at least 2500 individuals of both genders who are between 16 and 29 years of age at baseline. The recruitment will be pursued through several approaches including random sampling of the relevant population, as well as convenience sampling from clients of the Swedish National Tobacco Quitline (Sluta Röka Linjen) and of the public dentistry clinics (Folktandvården), or through media. The data collection will combine questionnaire- and register-based information as well as laboratory measurements. Approximately one year after the baseline assessment the participants will be re-surveyed. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 29 Years |
| Sex | All |
| Target sample size at registration | 2500 |
| Key inclusion criteria | 1. Age 16-29 years 2. Resident in Sweden 3. Able to understand and write the Swedish language 4. Providing informed consent to be included in the study |
| Key exclusion criteria | 1. Not resident in Sweden at enrolment 2. Inability to read and/or write the Swedish language 3. Not providing explicit consent to be included in the study |
| Date of first enrolment | 01/09/2026 |
| Date of final enrolment | 31/08/2027 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Sweden
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
30/07/2026: Study’s existence confirmed by the Swedish Ethical Review Authority.