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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

January 21, 2009
January 14, 2013
January 2009
September 2010   (final data collection date for primary outcome measure)
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
Biochemically-confirmed abstinence from smoking [ Time Frame: 7-day point prevalence ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00828113 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Long-term Varenicline Treatment for Smoking Cessation
Long-term Varenicline Treatment for Smoking Cessation

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Smoking
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
February 2011
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00828113
H-2008-0149
Yes
Douglas Jorenby, University of Wisconsin, Madison
University of Wisconsin, Madison
Pfizer
Not Provided
University of Wisconsin, Madison
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP