Status:
COMPLETED
Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
Lead Sponsor:
Pfizer
Conditions:
Tobacco Use Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT00717093
Start Date
August 1 2008
End Date
July 1 2009
Last Update
July 23 2015
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Florø, Norway, 6900
2
Pfizer Investigational Site
Hafrsfjord, Norway, 4042
3
Pfizer Investigational Site
Hamar, Norway, 2317
4
Pfizer Investigational Site
Hønefoss, Norway, 3515