NicotineSUCCESSNCT07573319
The SCAPIS-Snus Study
An observational study of Nicotine and Mental Health, run by Karolinska Institutet at 5 sites in Sweden.
Trial summary
Historically, snus use in Sweden was very stable, primarily used by about 20% of men and only 4-5% of women. However, the recent introduction of "white snus" (nicotine pouches) has dramatically changed this landscape. Read more about this study
- Who is it for?
- Ages 50 to 64 years
- Conditions the study is for
- Nicotine, Mental Health, Cardiovascular (CV) Risk
- How many people
- 30,154 participants
- Where
- 5 sitesSweden
- Study dates
- 1 Jan 2013to 31 Dec 2028
- How long will I take part?
- 10 Years
- 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 50 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Random selection
Who may be able to join
- Age 50-64 years at the time of inclusion
- Selection: Randomly selected from the Swedish national population register.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Göteborg Universitetssjukhus
Gothenburg
Skanes Universitetssjukhus, Lund Universitet
Lund
Karolinska Institutet Danderyds Sjukhus
Stockholm
Umeå Universitetssjukhus
Umeå
Uppsala Universitetssjukhus
Uppsala
About this study
Official title: The Association Between Snus Use and Cardiovascular Health, Metabolism, and Mental Health Based on SCAPIS 1 & 2
Historically, snus use in Sweden was very stable, primarily used by about 20% of men and only 4-5% of women. However, the recent introduction of "white snus" (nicotine pouches) has dramatically changed this landscape. Today, women are using snus at nearly the same rate as men, with the sharpest increase seen among young people.
Globally, snus is gaining massive popularity and is heavily marketed by major tobacco companies as a safe alternative to smoking cigarettes. But is it really safe?
Read more
Current research shows a mixed picture. Some studies suggest that snus users have stiffer arteries and face a higher risk of death if they suffer a heart attack or stroke. In fact, quitting snus after a heart attack can cut the risk of mortality in half. Conversely, other studies have found no clear link between snus and heart disease. Because of these scattered and confusing results, more comprehensive research is urgently needed.
What is the study trying to find out? The primary goal of this research is to see if using snus-completely independent of smoking cigarettes-is linked to negative health outcomes. The researchers have a strong hypothesis: they believe snus use may be associated with increased artery damage, higher blood pressure, poorer metabolic health, and higher stress levels.
Specifically, the study will investigate if snus use is connected to:
Heart and Blood Vessel Health: Is snus linked to a higher buildup of plaque in the coronary arteries (atherosclerosis), which can lead to heart attacks?
Metabolic Health: Does snus negatively affect cardiometabolic markers, such as cholesterol levels, blood sugar, body weight, waist circumference, and blood pressure?
Mental Well-being: Is there a connection between snus use and psychological distress, poor sleep, high stress levels, or increased sick leave?
How will the study be conducted?
To get the most accurate answers, the researchers are using data from SCAPIS (the Swedish Cardiopulmonary Bioimage Study), a massive, high-quality health study.
Following People Over Time: The researchers will look at data from two different time points: "SCAPIS 1" (the baseline) and "SCAPIS 2" (the follow-up). This allows them not only to take a snapshot of people's health but also to track how their health changes over time.
Comparing Different Groups: The study will compare people who have never used snus, former users, and current users. It will also look at how much snus people use, how long they have used it, and whether they use traditional tobacco snus or the newer white nicotine pouches.
Advanced Medical Testing: The study relies on thorough medical data, including advanced CT scans of the heart to look for plaque, detailed blood tests for cholesterol and inflammation, and comprehensive questionnaires regarding mental health and stress.
Importantly, the researchers will use advanced statistics to ensure that other lifestyle factors-like diet, exercise, alcohol use, and a history of smoking-do not skew the results. This ensures they are isolating the specific effects of snus.
Read the detailed description
In Sweden, the number of snus users has remained very stable for many years, with roughly 20 percent of men and approximately 4-5 percent of women classified as users. However, since the introduction of "white snus," usage has increased explosively among women, who now use snus at nearly the same rate as men. Once again, the youngest age groups account for this increase.
Snus use has also gained increasing international popularity. In the US, where Swedish-style portion snus was legalized in 2011, and snus is intensively marketed as an alternative to smoking.
Snus has long been considered a relatively risk-free alternative to tobacco smoking. However, snus users experience increased mortality associated with myocardial infarction and stroke, and studies have shown that mortality in patients with a previous myocardial infarction is halved among those who quit using snus after the infarction compared to those who continue. In experimental studies, investigators demonstrated that snus users who have used snus for more than 15 years exhibit increased arterial stiffness and respond more poorly to nitroglycerin. Other studies, however, have not demonstrated any association between snus use and coronary artery disease. These divergent results indicate that further research is needed to determine whether a genuine link exists between snus use and cardiovascular disease.
The objective is to investigate whether snus use is associated with: An increased degree of atherosclerosis and plaque formation on coronary computed tomography angiography (CCTA/CAC). Elevated cardiometabolic markers associated with an increased risk of cardiovascular diseases (NT-ProBNP, troponins, lipids, glucose, blood pressure, ankle pressure, waist circumference, weight, OGTT) Mental illness, stress, and sick leave.
Additionally, the objective is to explore how changes in snus use between SCAPIS 1 and 2 affect the progression of these factors.
Hypothesis: Snus use, independent of smoking, is associated with increased atherosclerosis and its complications, higher blood pressure, a poorer metabolic profile, and increased stress burden.
Data Material and Study Design:
Data Source: SCAPIS 1 (baseline) and SCAPIS 2 (follow-up).
Design:
Cross-sectional analysis (SCAPIS 1):
Exposure: snus; Outcome: CCTA/CAC, cardiometabolic markers, and mental illness.
Longitudinal analysis (SCAPIS 1→2):
Exposure: change in snus use; Outcome: progression of atherosclerosis, metabolic, and mental health outcomes
Study Sample:
Participants with data on tobacco use, CCTA/CAC, blood pressure, metabolic markers, mental health, and stress. Individuals with known CVD will be excluded.
- Keywords
- Snus, oral moist snuff, nicotine, mental health, depression, cardiovascular, atherosclerosis, metabolic profile
- Medical subject headings
- Psychological Well-Being, Depression, Atherosclerosis
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 |
|---|---|---|
| SCAPIS 1 | Swedish CArdioPulmonary bioImage Study. Baseline Study | |
| SCAPIS 2 | Swedish CArdioPulmonary bioImage Study 2. Follow up study on 15.000 participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of plaque, plaque burden (SIS/SSS)
CCTA/CAC: Presence of plaque, plaque burden (SIS/SSS), stenosis ≥50%, plaque type, Agatston score, as well as plaque distribution and appearance.
Measured: 10 Years
LDL
Measured: 10 years
SF-12 questionnaire
Mental Health Quality of Life
Measured: 10 Years
Sick leave days
Measured: 10 years
LOT-R
Life Orientation Test
Measured: 10 Years
HDL
Measured: 10 Years
ApolipoproteinA
Measured: 10 Years
Apolipoprotein B
Measured: 10 Years
Secondary outcomes (8)
Blood pressure
Measured: 10 years
HbA1c
Measured: 10 years
Weight
Measured: 10 years
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI)
Measured: 10 years
Arterial Stiffness
Arterial Stiffness
Measured: 10 years
Length
Length
Measured: 10 Years
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI)
Measured: 10 Years
Epworth Sleepiness Scale
Epworth Sleepiness Scale
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jan 2013
- Primary completion31 Dec 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NicotineStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 30,154 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, Uppsala University Hospital, University Hospital, Umeå, Lund University Hospital, Department of clinical sciences at Danderyd hospital
- Responsible party
- Principal investigator, Magnus Lundbäck, Karolinska Institutet
- Investigators
- Magnus Lundback, Prof., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573319
- Sponsor's protocol ID
- 2025-01975-02
- Other IDs
- 2021-00549, 2022-00117-02, 2025
- Acronym
- SUCCESS
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requirements for data access are online: https://www.scapis.org/how-to-apply/requirements/
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Snus Use and Cardiovascular Health, Metabolism, and Mental Health Based on SCAPIS 1 & 2
- ClinicalTrials.gov ID
- NCT07573319
- Acronym / sponsor ID
- SUCCESS / 2025-01975-02
- Keywords
- Snus, oral moist snuff, nicotine, mental health, depression, cardiovascular, atherosclerosis, metabolic profile
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30,154 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Medical University of Vienna, Uppsala University Hospital, University Hospital, Umeå, Lund University Hospital, Department of clinical sciences at Danderyd hospital
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 May 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.
Historically, snus use in Sweden was very stable, primarily used by about 20% of men and only 4-5% of women. However, the recent introduction of "white snus" (nicotine pouches) has dramatically changed this landscape. Today, women are using snus at nearly the same rate as men, with the sharpest increase seen among young people.
Globally, snus is gaining massive popularity and is heavily marketed by major tobacco companies as a safe alternative to smoking cigarettes. But is it really safe?
Current research shows a mixed picture. Some studies suggest that snus users have stiffer arteries and face a higher risk of death if they suffer a heart attack or stroke. In fact, quitting snus after a heart attack can cut the risk of mortality in half. Conversely, other studies have found no clear link between snus and heart disease. Because of these scattered and confusing results, more comprehensive research is urgently needed.
What is the study trying to find out? The primary goal of this research is to see if using snus-completely independent of smoking cigarettes-is linked to negative health outcomes. The researchers have a strong hypothesis: they believe snus use may be associated with increased artery damage, higher blood pressure, poorer metabolic health, and higher stress levels.
Specifically, the study will investigate if snus use is connected to:
Heart and Blood Vessel Health: Is snus linked to a higher buildup of plaque in the coronary arteries (atherosclerosis), which can lead to heart attacks?
Metabolic Health: Does snus negatively affect cardiometabolic markers, such as cholesterol levels, blood sugar, body weight, waist circumference, and blood pressure?
Mental Well-being: Is there a connection between snus use and psychological distress, poor sleep, high stress levels, or increased sick leave?
How will the study be conducted?
To get the most accurate answers, the researchers are using data from SCAPIS (the Swedish Cardiopulmonary Bioimage Study), a massive, high-quality health study.
Following People Over Time: The researchers will look at data from two different time points: "SCAPIS 1" (the baseline) and "SCAPIS 2" (the follow-up). This allows them not only to take a snapshot of people's health but also to track how their health changes over time.
Comparing Different Groups: The study will compare people who have never used snus, former users, and current users. It will also look at how much snus people use, how long they have used it, and whether they use traditional tobacco snus or the newer white nicotine pouches.
Advanced Medical Testing: The study relies on thorough medical data, including advanced CT scans of the heart to look for plaque, detailed blood tests for cholesterol and inflammation, and comprehensive questionnaires regarding mental health and stress.
Importantly, the researchers will use advanced statistics to ensure that other lifestyle factors-like diet, exercise, alcohol use, and a history of smoking-do not skew the results. This ensures they are isolating the specific effects of snus.
Detailed description
In Sweden, the number of snus users has remained very stable for many years, with roughly 20 percent of men and approximately 4-5 percent of women classified as users. However, since the introduction of "white snus," usage has increased explosively among women, who now use snus at nearly the same rate as men. Once again, the youngest age groups account for this increase.
Snus use has also gained increasing international popularity. In the US, where Swedish-style portion snus was legalized in 2011, and snus is intensively marketed as an alternative to smoking.
Snus has long been considered a relatively risk-free alternative to tobacco smoking. However, snus users experience increased mortality associated with myocardial infarction and stroke, and studies have shown that mortality in patients with a previous myocardial infarction is halved among those who quit using snus after the infarction compared to those who continue. In experimental studies, investigators demonstrated that snus users who have used snus for more than 15 years exhibit increased arterial stiffness and respond more poorly to nitroglycerin. Other studies, however, have not demonstrated any association between snus use and coronary artery disease. These divergent results indicate that further research is needed to determine whether a genuine link exists between snus use and cardiovascular disease.
The objective is to investigate whether snus use is associated with: An increased degree of atherosclerosis and plaque formation on coronary computed tomography angiography (CCTA/CAC). Elevated cardiometabolic markers associated with an increased risk of cardiovascular diseases (NT-ProBNP, troponins, lipids, glucose, blood pressure, ankle pressure, waist circumference, weight, OGTT) Mental illness, stress, and sick leave.
Additionally, the objective is to explore how changes in snus use between SCAPIS 1 and 2 affect the progression of these factors.
Hypothesis: Snus use, independent of smoking, is associated with increased atherosclerosis and its complications, higher blood pressure, a poorer metabolic profile, and increased stress burden.
Data Material and Study Design:
Data Source: SCAPIS 1 (baseline) and SCAPIS 2 (follow-up).
Design:
Cross-sectional analysis (SCAPIS 1):
Exposure: snus; Outcome: CCTA/CAC, cardiometabolic markers, and mental illness.
Longitudinal analysis (SCAPIS 1→2):
Exposure: change in snus use; Outcome: progression of atherosclerosis, metabolic, and mental health outcomes
Study Sample:
Participants with data on tobacco use, CCTA/CAC, blood pressure, metabolic markers, mental health, and stress. Individuals with known CVD will be excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCAPIS 1 | – | –Swedish CArdioPulmonary bioImage Study. Baseline Study |
| SCAPIS 2 | – | –Swedish CArdioPulmonary bioImage Study 2. Follow up study on 15.000 participants |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Random selection
Key inclusion criteria (2 listed)
- Age 50-64 years at the time of inclusion
- Selection: Randomly selected from the Swedish national population register.
Key exclusion criteria (0 listed)
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
Presence of plaque, plaque burden (SIS/SSS)
Time frame: 10 Years
CCTA/CAC: Presence of plaque, plaque burden (SIS/SSS), stenosis ≥50%, plaque type, Agatston score, as well as plaque distribution and appearance.
LDL
Time frame: 10 years
SF-12 questionnaire
Time frame: 10 Years
Mental Health Quality of Life
Sick leave days
Time frame: 10 years
LOT-R
Time frame: 10 Years
Life Orientation Test
HDL
Time frame: 10 Years
ApolipoproteinA
Time frame: 10 Years
Apolipoprotein B
Time frame: 10 Years
8 secondary outcomes
Blood pressure
Time frame: 10 years
HbA1c
Time frame: 10 years
Weight
Time frame: 10 years
Insomnia Severity Index (ISI)
Time frame: 10 years
Arterial Stiffness
Time frame: 10 years
Length
Time frame: 10 Years
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 10 Years
Epworth Sleepiness Scale
Time frame: 10 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 12 May 2026.
- Individual participant dataSharing planned: No. Requirements for data access are online: https://www.scapis.org/how-to-apply/requirements/
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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. This study is not recruiting at the moment.
Magnus Lundback, Prof. principal investigator
Karolinska Institutet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine and Mental Health, run by Karolinska Institutet at 5 sites in Sweden.
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 2 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of plaque, plaque burden (SIS/SSS) (time frame: 10 Years). The study lists 8 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 12 May 2026.