Status:
COMPLETED
Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers
Lead Sponsor:
Swedish Match AB
Conditions:
Cigarette Smoking
Eligibility:
All Genders
25-65 years
Phase:
PHASE4
Brief Summary
The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking
Detailed Description
In a multicenter, double-blind, placebo-controlled setting, participants are randomly allocated to either a smokefree, oral tobacco product or a non-tobacco, non-nicotine placebo product with identica...
Eligibility Criteria
Inclusion
- Cigarette smoker who smoke more than 9 cigarettes per day (average during past month)
- Daily smoking more than 1 year
- Motivated to quit smoking using a smokefree tobacco product
- Good general health
Exclusion
- Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical product for smoking cessation during past 3 months
- Unable to refrain from nicotine replacement therapy during the study
- Current oral condition that could be made worse by study interventions
- History of clinically significant renal, hepatic, neurological, or chronic pulmonary disease that in the judgement of the investigator might preclude participation
- History of significant cardiovascular disease, including myocardial infarction, within the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension that in the judgement of the investigator might preclude participation
- History of alcohol or substance abuse other than cigarette smoking within the past year
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00843622
Start Date
February 1 2009
End Date
June 1 2010
Last Update
June 17 2014
Active Locations (4)
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1
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117
2
Covance Clinical Research Unit
Evansville, Indiana, United States, 47710
3
Covance Clinical Research Unit
Portland, Oregon, United States, 97239
4
Covance Clinical Research Unit
Austin, Texas, United States, 78752