Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00717093

Purpose

The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

Condition	Intervention	Phase
Tobacco Use Cessation	Drug: Varenicline Tartrate Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

Resource links provided by NLM:

MedlinePlus related topics: Smokeless Tobacco

Drug Information available for: Varenicline Varenicline tartrate

Further study details as provided by Pfizer:

Primary Outcome Measures:

To compare the efficacy of varenicline to placebo for cessation of use of smokeless tobacco assessed using the 4-week Continuous Quit Rate (CQR) at the end of treatment (Week 12). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare varenicline with placebo for the Long Term Quit Rate (LTQR) of smokeless tobacco from Week 9 through to 26. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To assess the safety and tolerability of varenicline with placebo, for 12 weeks of treatment in users of smokeless tobacco. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To compare varenicline with placebo for the Continuous Abstinence (CA) of smokeless tobacco from Week 9 through to 26. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Compare varenicline with placebo for the 7 day Point Prevalence (PP) of abstinence at the end of treatment (Week 12). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Compare varenicline with placebo for the 7 day Point Prevalence (PP) of abstinence at the end of study (Week 26). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	430
Study Start Date:	August 2008
Study Completion Date:	July 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	Drug: Varenicline Tartrate Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
Placebo: Placebo Comparator	Drug: Placebo Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

Eligibility

Criteria

Inclusion Criteria:

Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year.

Exclusion Criteria:

Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline.
Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717093

Locations

Norway
Pfizer Investigational Site
Oslo, Norway, 0407
Pfizer Investigational Site
Hønefoss, Norway, 3515
Pfizer Investigational Site
Hafrsfjord, Norway, 4042
Pfizer Investigational Site
5235 Radal, Norway
Pfizer Investigational Site
Floro, Norway, 6900
Pfizer Investigational Site
Trondheim, Norway, 7034
Norway, 2317
Pfizer Investigational Site
Hamar, 2317, Norway
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 118 91
Pfizer Investigational Site
Karlstad, Sweden, 652 24,
Pfizer Investigational Site
Orebro, Sweden, 701 85
Pfizer Investigational Site
Sodertalje, Sweden, 151 87
Pfizer Investigational Site
Umea, Sweden, 901 85
Pfizer Investigational Site
Jarfalla, Sweden, 177 31
Pfizer Investigational Site
Göteborg, Sweden, 413 45
Pfizer Investigational Site
Sundsvall, Sweden, 852 31
Pfizer Investigational Site
Helsingborg, Sweden, 254 52

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051104
Study First Received:	July 15, 2008
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00717093 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Study placed in the following topic categories:

Lobeline
Varenicline

ClinicalTrials.gov processed this record on September 10, 2009