NCT07573319

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,154

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jan 2013Dec 2028

Study Start

First participant enrolled

January 1, 2013

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

13 years

First QC Date

April 24, 2026

Last Update Submit

May 3, 2026

Conditions

Keywords

Snusoral moist snuffnicotinemental healthdepressioncardiovascularatherosclerosismetabolic profile

Outcome Measures

Primary Outcomes (5)

  • 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.

    10 Years

  • Lipids: LDL, HDL, TG, ApoB/ApoA1, Lp(a)

    10 years

  • SF-12 questionnaire

    Mental Health Quality of Life

    10 Years

  • Sick leave days

    10 years

  • LOT-R

    Life Orientation Test

    10 Years

Secondary Outcomes (8)

  • Blood pressure

    10 years

  • HbA1c

    10 years

  • Weight

    10 years

  • Insomnia Severity Index (ISI)

    10 years

  • Arterial Stiffness

    10 years

  • +3 more secondary outcomes

Study Arms (2)

SCAPIS 1

Swedish CArdioPulmonary bioImage Study. Baseline Study

SCAPIS 2

Swedish CArdioPulmonary bioImage Study 2. Follow up study on 15.000 participants

Eligibility Criteria

Age50 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Random selection

Individuals aged 50-64 years at the time of inclusion Selection: Randomly selected from the Swedish national population register. Cohort Size: Over 30,000 men and women. Locations: Recruited across six Swedish university hospitals: Gothenburg, Malmö/Lund, Linköping, Stockholm, Umeå, and Uppsala.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Göteborg Universitetssjukhus

Gothenburg, Sweden

Location

Skanes Universitetssjukhus, Lund Universitet

Lund, Sweden

Location

Karolinska Institutet Danderyds Sjukhus

Stockholm, Sweden

Location

Umeå Universitetssjukhus

Umeå, Sweden

Location

Uppsala Universitetssjukhus

Uppsala, Sweden

Location

MeSH Terms

Conditions

Psychological Well-BeingDepressionAtherosclerosis

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Magnus Lundback, Prof.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 7, 2026

Study Start

January 1, 2013

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Requirements for data access are online: https://www.scapis.org/how-to-apply/requirements/

Locations