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

NCT ID: NCT00843622

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-06-30

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 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.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Low-nitrosamine smokefree tobacco product for oral use

Intervention Type: DRUG

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.

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

Group Type: PLACEBO_COMPARATOR

Non-tobacco, non-nicotine placebo product

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Swedish tobacco-based smokefree product for oral use ("General"-type Swedish "snus"); Placebo "snus" ("Onico"-type product)

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swedish Match AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Fagerström, Ph. D.

Role: STUDY_CHAIR

Smoker's Information Center, Hälsingborg, Sweden

Randall R Stoltz, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit, Evansville, In

Frank H Farmer, Jr, MD, Ph D, CPI

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit, Daytona Beach, FL

David C Carter, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit, Austin, TX

Keith Klatt, MD

Role: PRINCIPAL_INVESTIGATOR

Covance Clinical Research Unit, Portland, OR

Locations

Covance Clinical Research Unit

Daytona Beach, Florida, United States

Covance Clinical Research Unit

Evansville, Indiana, United States

Covance Clinical Research Unit

Portland, Oregon, United States

Covance Clinical Research Unit

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21994343 (View on PubMed)

Other Identifiers

SM 08-01

Identifier Type: -

Identifier Source: org_study_id