Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
NCT ID: NCT00717093
Last Updated: 2015-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
432 participants
INTERVENTIONAL
2008-08-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active
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
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.
Interventions
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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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Florø, , Norway
Pfizer Investigational Site
Hafrsfjord, , Norway
Pfizer Investigational Site
Hamar, , Norway
Pfizer Investigational Site
Hønefoss, , Norway
Pfizer Investigational Site
Oslo, , Norway
Pfizer Investigational Site
Rådal, , Norway
Pfizer Investigational Site
Trondheim, , Norway
Pfizer Investigational Site
Gothenburg, , Sweden
Pfizer Investigational Site
Helsingborg, , Sweden
Pfizer Investigational Site
Jarfalla, , Sweden
Pfizer Investigational Site
Karlstad, , Sweden
Pfizer Investigational Site
Örebro, , Sweden
Pfizer Investigational Site
Södertälje, , Sweden
Pfizer Investigational Site
Stockholm, , Sweden
Pfizer Investigational Site
Sundsvall, , Sweden
Pfizer Investigational Site
Umeå, , Sweden
Countries
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References
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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Fagerstrom K, Gilljam H, Metcalfe M, Tonstad S, Messig M. Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial. BMJ. 2010 Dec 6;341:c6549. doi: 10.1136/bmj.c6549.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051104
Identifier Type: -
Identifier Source: org_study_id
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