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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Smoking
 Drug: varenicline
Behavioral: Individual smoking cessation counseling
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Varenicline Treatment for Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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


Enrollment: 101
Study Start Date: January 2009
Study Completion Date: February 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended treatment
52-week varenicline therapy + individual smoking cessation counseling
 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
Active Comparator: Standard treatment
13 weeks of varenicline therapy + individual smoking cessation counseling
 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828113

Locations
United States, Wisconsin
Center for Tobacco Research and Intervention
Madison, Wisconsin, United States, 53711
Center for Tobacco Research and Intervention
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
University of Wisconsin, Madison
Pfizer
  More Information

No publications provided

Responsible Party: Douglas Jorenby, Professor of Medicine, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00828113     History of Changes
Other Study ID Numbers: H-2008-0149
Study First Received: January 21, 2009
Results First Received: June 13, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
smoking
relapse
withdrawal

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013