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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Prof Maria Rosaria Galanti
Principal investigator, Scientific

Department of Global Public Health, Karolinska Institutet
Tomtebodavägen 18A
Stockholm
17165
Sweden

ORCiD logoORCID ID 0000-0002-7805-280X
Phone +46 70 254 12 86
Email rosaria.galanti@ki.se
Mr Erik Harald Anund
Public

Department of Global Public Health, Karolinska Institutet
Tomtebodavägen 18A
Stockholm
17165
Sweden

Phone +46 70 254 12 86
Email erik.harald.anund@ki.se

Study information

Primary study designObservational
Observational study designLongitudinal study
Scientific titleUse 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 acronymUNIKA
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) studiedUse of non-combustible nicotine and tobacco products (NCNT)
MethodologyThis 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 typeOther
Primary outcome measure(s)
  1. Current use of NCNT measured using self-reported past 30-day use of NCNT at baseline and 1-year follow-up
Key secondary outcome measure(s)
  1. Initiation of use of NCNT measured using self-reported in questionnaire at 1-year follow-up
  2. Cessation of use measured using self-reported in questionnaire at 1-year follow-up
  3. Nicotine dependence from NCNT measured using self reported in questionnaire (scale) at baseline and 1-year follow-up
  4. Average dose of absorbed nicotine from NCNT measured using an ELISA to quantify cotinine in saliva at baseline and/or 1-year follow-up
Completion date31/12/2028

Eligibility

Participant type(s)
Age groupMixed
Lower age limit16 Years
Upper age limit29 Years
SexAll
Target sample size at registration2500
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2026
Date of final enrolment31/08/2027

Locations

Countries of recruitment

  • Sweden

Study participating centres

University of Gothenburg (Sweden)
Gothenburg
Sweden
Centre for Epidemiology and Community Medicine, Region of Stockholm
Stockholm
Sweden

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

30/07/2026: Study’s existence confirmed by the Swedish Ethical Review Authority.