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Long-term Varenicline Treatment for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00828113
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : July 18, 2012
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Smoking Drug: varenicline Behavioral: Individual smoking cessation counseling Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Varenicline Treatment for Smoking Cessation
Study Start Date : January 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00828113     History of Changes
Other Study ID Numbers: H-2008-0149
First Posted: January 23, 2009    Key Record Dates
Results First Posted: July 18, 2012
Last Update Posted: November 20, 2015
Last Verified: October 2015

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

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