Long-term Varenicline Treatment for Smoking Cessation

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Douglas Jorenby, University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT00828113

First received: January 21, 2009

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 21, 2009
Last Updated Date	January 14, 2013
Start Date ^ICMJE	January 2009
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 14, 2013)	Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 [ Time Frame: 7-day point prevalence ] [ Designated as safety issue: No ] Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of < 10 parts per million as assessed at Week 52
Original Primary Outcome Measures ^ICMJE (submitted: January 21, 2009)	Biochemically-confirmed abstinence from smoking [ Time Frame: 7-day point prevalence ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00828113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Long-term Varenicline Treatment for Smoking Cessation
Official Title ^ICMJE	Long-term Varenicline Treatment for Smoking Cessation
Brief Summary	This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Smoking
Intervention ^ICMJE	Drug: varenicline Extension of 1 mg twice daily treatment to 52 weeks Drug: varenicline Double-blind switch to placebo after 12 weeks of open-label therapy Behavioral: Individual smoking cessation counseling Brief (<10 minutes) smoking cessation counseling delivered at clinic visits
Study Arm (s)	Experimental: Extended treatment 52-week varenicline therapy + individual smoking cessation counseling Interventions: Drug: varenicline Drug: varenicline Behavioral: Individual smoking cessation counseling Active Comparator: Standard treatment 13 weeks of varenicline therapy + individual smoking cessation counseling Interventions: Drug: varenicline Drug: varenicline Behavioral: Individual smoking cessation counseling
Publications *	Not Provided
* 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
Enrollment ^ICMJE	101
Completion Date	February 2011
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: daily smoker 5+ cigarettes per day for at least one year expired carbon monoxide level of 5+ ppm Exclusion Criteria: current use of smoking cessation pharmacotherapies current or history of psychotic disorder current major depressive disorder history of suicidal ideation in the previous 3 months unstable medical condition pregnant, nursing, or planning to become pregnant planning to move from study area within 18 months
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00828113
Other Study ID Numbers ^ICMJE	H-2008-0149
Has Data Monitoring Committee	Yes
Responsible Party	Douglas Jorenby, University of Wisconsin, Madison
Study Sponsor ^ICMJE	University of Wisconsin, Madison
Collaborators ^ICMJE	Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	University of Wisconsin, Madison
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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