Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843622
• Other study ID #: SM 08-01
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2009
• Last updated: May 15, 2014
• Start date: February 2009
• Est. completion date: June 2010

Study information

• 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

Clinical Trial 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

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 identical flavoring and physical appearance. The study consists of three phases: Study Product Test Period (4 weeks), Intervention Phase (12 weeks), and a Follow-Up Phase (12 weeks). The participants are all cigarette smokers who are motivated to quit. They are encouraged to gradually substitute as many cigarettes as possible with study products during the Study Product Test Period and to refrain from all cigarettes at the latest by the first day of Week 5. Use of study products will continue during the 12 week Intervention Phase. The participants are encouraged to cut down on use of study products during the last 3 weeks to avoid a too abrupt ending of nicotine intake.

All subjects are encouraged to continue in the study for clinical follow-up independent of smoking status although use of study products is discontinued during the Follow-Up Phase. If a subject has managed to quit smoking during the Intervention Phase but there is an imminent danger of smoking relapse during the Follow-Up Phase, that subject is informed that use of nicotine replacement therapy or a smokefree tobacco product is a better option in terms of health risks than a smoking relapse.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Drug:
• Low-nitrosamine smokefree tobacco product for oral use
Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.

Other:
• Non-tobacco, non-nicotine placebo product
Placebo product in paper sachets containing 1.0 or 0.5 g. Product made of cocoa bean fibers and oat fibers. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Match AB

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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