Cigarette Smoking Clinical Trial
Official title:
A Controlled Study of the Ability of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Increase the Quit Rate Among Cigarette Smokers Who Wish to Stop Smoking
Verified date | May 2014 |
Source | Swedish Match AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 250 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 25 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Covance Clinical Research Unit | Austin | Texas |
United States | Covance Clinical Research Unit | Daytona Beach | Florida |
United States | Covance Clinical Research Unit | Evansville | Indiana |
United States | Covance Clinical Research Unit | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Swedish Match AB |
United States,
Fagerstrom K, Rutqvist LE, Hughes JR. Snus as a smoking cessation aid: a randomized placebo-controlled trial. Nicotine Tob Res. 2012 Mar;14(3):306-12. doi: 10.1093/ntr/ntr214. Epub 2011 Oct 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm | Week 6-28 | No | |
Secondary | Minnesota Nicotine Withdrawal Scale | Baseline, week 6, 10, 16 and 28 | No | |
Secondary | Fagerström Test for Nicotine Dependence | Baseline, week 16 and 28 | No | |
Secondary | Biomarkers | Baseline, week 6, 16, and 28 | Yes | |
Secondary | Point Prevalence Smoking Cessation | 7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less | 6, 16, 28 weeks | No |
Secondary | Continuous Smoking Cessation | Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits | 6-16 weeks | No |
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