NCT00717093

Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Tobacco Use Cessation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-04-01
• Completion: 2009-07-01
• First posted: 2008-07-16
• Last updated: 2015-07-23
• Results posted: 2010-05-18

Locations

16 sites across 2 countries: Norway, Sweden