Serbian Smoking Reduction/Cessation Trial (2SRT)

Swedish Match AB

Status and phase: Completed; Phase 4

Conditions: Cigarette Smoking

Treatments: Other: Swedish snus (smokeless tobacco); Other: Onico

Study type: Interventional

Funder types: Industry

Identifiers

NCT00601042

SM 07-01

Details and patient eligibility

About

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.

Enrollment: 319 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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319 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Swedish snus ad libitum as a substitute for cigarettes

Treatment:

Other: Swedish snus (smokeless tobacco)

2

Placebo Comparator group

Description:

Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes

Treatment:

Other: Onico