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

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

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

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Drug: Low-nitrosamine smokefree tobacco product for oral use; Other: Non-tobacco, non-nicotine placebo product

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 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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Unit
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Covance Clinical Research Unit
  • Oregon
    • Portland, Oregon, United States, 97239
      • Covance Clinical Research Unit
  • Texas
    • Austin, Texas, United States, 78752
      • Covance Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Tobacco-based, smokefree product in pouch format for oral use, pouch size 1.0 or 0.5 g to be used ad libitum by participants	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 Names: Swedish tobacco-based smokefree product for oral use ("General"-type Swedish "snus"); Placebo "snus" ("Onico"-type product)
Placebo Comparator: 2; Non-tobacco, non-nicotine placebo product in pouch format for oral use, pouch size 1.0 g or 0.5 g, to be used ad libitum by the participants	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm	Week 6-28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minnesota Nicotine Withdrawal Scale		Baseline, week 6, 10, 16 and 28
Fagerström Test for Nicotine Dependence		Baseline, week 16 and 28
Biomarkers		Baseline, week 6, 16, and 28
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
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

Collaborators and Investigators

• Sponsor: Swedish Match AB
• Investigators: Study Chair: Karl Fagerström, Ph. D., Smoker's Information Center, Hälsingborg, Sweden; Principal Investigator: Randall R Stoltz, MD, Covance Clinical Research Unit, Evansville, In; Principal Investigator: Frank H Farmer, Jr, MD, Ph D, CPI, Covance Clinical Research Unit, Daytona Beach, FL; Principal Investigator: David C Carter, MD, Covance Clinical Research Unit, Austin, TX; Principal Investigator: Keith Klatt, MD, Covance Clinical Research Unit, Portland, OR

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: February 12, 2009
• First Submitted That Met QC Criteria: February 12, 2009
• First Posted (Estimate): February 13, 2009

Study Record Updates

• Last Update Posted (Estimate): June 17, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Smoking; Smoking cessation; Smokeless tobacco; Snus
• Other Study ID Numbers: SM 08-01