Clinical trial NCT00843622: Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cigarette Smoking
Keywords: Smoking
Smoking cessation
Smokeless tobacco
Snus
Lead sponsor: Swedish Match AB
Sponsor class: INDUSTRY
First posted: 2009-02-13
Enrollment: 250
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm
timeFrame: Week 6-28
Secondary outcomes:
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Baseline, week 6, 10, 16 and 28
measure: Fagerström Test for Nicotine Dependence
timeFrame: Baseline, week 16 and 28
measure: Biomarkers
timeFrame: Baseline, week 6, 16, and 28
measure: Point Prevalence Smoking Cessation
timeFrame: 6, 16, 28 weeks
measure: Continuous Smoking Cessation
timeFrame: 6-16 weeks
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit
state: Florida
city: Evansville
country: United States
facility: Covance Clinical Research Unit
state: Indiana
city: Portland
country: United States
facility: Covance Clinical Research Unit
state: Oregon
city: Austin
country: United States
facility: Covance Clinical Research Unit
state: Texas
Study officials:
affiliation: Smoker's Information Center, Hälsingborg, Sweden
name: Karl Fagerström, Ph. D.
role: STUDY_CHAIR
affiliation: Covance Clinical Research Unit, Evansville, In
name: Randall R Stoltz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Covance Clinical Research Unit, Daytona Beach, FL
name: Frank H Farmer, Jr, MD, Ph D, CPI
role: PRINCIPAL_INVESTIGATOR
affiliation: Covance Clinical Research Unit, Austin, TX
name: David C Carter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Covance Clinical Research Unit, Portland, OR
name: Keith Klatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.