Cigarette Smoking
Conditions
Keywords
smoking reduction, smoking cessation, randomized trial, Swedish snus, smokeless tobacco
Brief summary
The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus) can help adult smokers to reduce and eventually completely quit smoking.
Interventions
OTHERSwedish snus (smokeless tobacco)
Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
OTHEROnico
Tobacco-free, nicotine-free placebo snus, 2 sachet sizes (1.0 g, 0.5 g), 2 flavors (same as in the experimental arm). Usage ad libitum.
Sponsors
Swedish Match AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female smokers in good general health aged 20-65 years regularly smoking \>10 cigarettes per day for more than 1 year who are motivated to reduce or quit smoking
Exclusion criteria
* Subjects with uncontrolled hypertension, history of coronary heart disease or other significant heart condition * History of other significant medical condition that might interfere with study procedures * Pregnant or nursing mother * Current drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Smoking reduction defined as a reduction in self-reported number of smoked cigarettes per day >50% compared to base-line, verified by a reduction in CO in exhaled air of >1 ppm compared to base-line | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm | 3, 6, 9 and 12 months | — |
| Clinical tests and biomarkers relevant for exposure to tobacco | 3, 6, 9, and 12 months | — |
| Smoking reduction | 12, 24, 36 and 48 months | Smoking reduction according to self-report |
Countries
Serbia
Outcome results
None listed