Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
NCT00717093
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use | |||
Official Title ICMJE | A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use | |||
Brief Summary | The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Tobacco Use Cessation | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Fagerström 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 432 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2009 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Norway, Sweden | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00717093 | |||
Other Study ID Numbers ICMJE | A3051104 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |