Serbian Smoking Reduction/Cessation Trial (2SRT) - Full Text View

Sponsor:	Swedish Match AB
Information provided by:	Swedish Match AB
ClinicalTrials.gov Identifier:	NCT00601042

Purpose

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.

Condition	Intervention	Phase
Cigarette Smoking	Other: Swedish snus (smokeless tobacco) Other: Onico	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Randomized, Placebo-controlled, Double-blind, Phase IV Trial to Assess the Efficacy of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Reduce or Replace Cigarette Smoking Among Adult Smokers in Serbia

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smokeless Tobacco Smoking

Drug Information available for: Lobeline Lobeline sulfate

U.S. FDA Resources

Further study details as provided by Swedish Match AB:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Clinical tests and biomarkers relevant for exposure to tobacco [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
Smoking reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Swedish snus ad libitum as a substitute for cigarettes	Other: Swedish snus (smokeless tobacco) Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
2: Placebo Comparator Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes	Other: Onico 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

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601042

Locations

Serbia
Institute of Nuclear Sciences "Vinca"
Belgrade, Serbia, 11001
Ambulanta Medicine Rada, Nis-Jugopetrol
Novi Beograd, Serbia, 110 70

Sponsors and Collaborators

Swedish Match AB

Investigators

Principal Investigator:	Gordana Joksic, Ph D	Institute for Nuclear Research "Vinca", Belgrade, Serbia
Study Chair:	Robert Nilsson, Ph D, Prof	Stockholm University, Stockholm, Sweden

More Information

No publications provided

Responsible Party:	Swedish Match AB ( Lars E Rutqvist, Senior Vice President Scientific Affairs )
ClinicalTrials.gov Identifier:	NCT00601042 History of Changes
Other Study ID Numbers:	SM 07-01, SM 07-01
Study First Received:	December 27, 2007
Last Updated:	September 3, 2009
Health Authority:	Serbia:Eticki komitet, Institut Nuklearne nauke "Vinca"

Keywords provided by Swedish Match AB:

smoking reduction
smoking cessation
randomized trial
Swedish snus
smokeless tobacco

Additional relevant MeSH terms:

Smoking
Habits
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2010