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

NCT00843622 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2014-06-17

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Swedish Match AB

    lead INDUSTRY

Principal Investigators

  • Karl Fagerström, Ph. D. · Smoker's Information Center, Hälsingborg, Sweden

  • Randall R Stoltz, MD · Covance Clinical Research Unit, Evansville, In

  • Frank H Farmer, Jr, MD, Ph D, CPI · Covance Clinical Research Unit, Daytona Beach, FL

  • David C Carter, MD · Covance Clinical Research Unit, Austin, TX

  • Keith Klatt, MD · Covance Clinical Research Unit, Portland, OR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00843622 on ClinicalTrials.gov