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

NCT00843622 | Completed Phase 4 Results

• 1 other identifier: SM 08-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

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

Conditions

Cigarette Smoking

Keywords

Smoking; Smoking cessation; Smokeless tobacco; Snus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  6, 16, 28 weeks

• Continuous Smoking Cessation

  6-16 weeks

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

Low-nitrosamine smokefree tobacco product for oral use 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.

Also known as: Swedish tobacco-based smokefree product for oral use ("General"-type Swedish "snus"), Placebo "snus" ("Onico"-type product)

1

Non-tobacco, non-nicotine placebo product 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.

2

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swedish Match AB: lead

Study Sites (4)

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Covance Clinical Research Unit

Evansville, Indiana, 47710, United States

Location

Covance Clinical Research Unit

Portland, Oregon, 97239, United States

Location

Covance Clinical Research Unit

Austin, Texas, 78752, United States

Location

Related 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.

  PMID: 21994343 RESULT

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Smoking Cessation; Tobacco Use

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Health Behavior

Results Point of Contact

• Title: Dr Karl Fagerström
• Organization: Fagerström Consulting AB

karl.fagerstrom@swipnet.se

Study Officials

• Karl Fagerström, Ph. D.

  Smoker's Information Center, Hälsingborg, Sweden

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-05

Locations

US (4)