Serbian Smoking Reduction/Cessation Trial (2SRT)

Swedish Match AB319 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

319

Conditions

Cigarette Smoking

Interventions

Swedish snus (smokeless tobacco)OTHER

Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.

OnicoOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Institute of Nuclear Sciences "Vinca"

Belgrade, Serbia

Ambulanta Medicine Rada, Nis-Jugopetrol

New Belgrade, Serbia

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm

Time frame: 3, 6, 9 and 12 months

Clinical tests and biomarkers relevant for exposure to tobacco

Time frame: 3, 6, 9, and 12 months

Smoking reduction

Smoking reduction according to self-report

Time frame: 12, 24, 36 and 48 months

Smoking reduction

Smoking reduction compared to baseline according to self-report

Time frame: 12, 24, 36 and 48 months

Data from ClinicalTrials.gov

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