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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swedish Match AB
ClinicalTrials.gov Identifier:
NCT00843622
First received: February 12, 2009
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Cigarette Smoking
Drug: Low-nitrosamine smokefree tobacco product for oral use
Other: Non-tobacco, non-nicotine placebo product
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Swedish Match AB:

Primary Outcome Measures:
  • Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm [ Time Frame: Week 6-28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minnesota Nicotine Withdrawal Scale [ Time Frame: Baseline, week 6, 10, 16 and 28 ] [ Designated as safety issue: No ]
  • Fagerström Test for Nicotine Dependence [ Time Frame: Baseline, week 16 and 28 ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: Baseline, week 6, 16, and 28 ] [ Designated as safety issue: Yes ]
  • Point Prevalence Smoking Cessation [ Time Frame: 6, 16, 28 weeks ] [ Designated as safety issue: No ]
    7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less

  • Continuous Smoking Cessation [ Time Frame: 6-16 weeks ] [ Designated as safety issue: No ]
    Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits


Enrollment: 250
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843622

Locations
United States, Florida
Covance Clinical Research Unit
Daytona Beach, Florida, United States, 32117
United States, Indiana
Covance Clinical Research Unit
Evansville, Indiana, United States, 47710
United States, Oregon
Covance Clinical Research Unit
Portland, Oregon, United States, 97239
United States, Texas
Covance Clinical Research Unit
Austin, Texas, United States, 78752
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Swedish Match AB
ClinicalTrials.gov Identifier: NCT00843622     History of Changes
Other Study ID Numbers: SM 08-01
Study First Received: February 12, 2009
Results First Received: May 15, 2014
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Match AB:
Smoking
Smoking cessation
Smokeless tobacco
Snus

Additional relevant MeSH terms:
Smoking
Habits
Lobeline
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014