Long-term Varenicline Treatment for Smoking Cessation

Smoking Clinical Trial

Official title:

Long-term Varenicline Treatment for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828113
• Other study ID #: H-2008-0149
• Status: Completed
• Phase: Phase 4
• First received: January 21, 2009
• Last updated: October 22, 2015
• Start date: January 2009
• Est. completion date: February 2011

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• varenicline
Extension of 1 mg twice daily treatment to 52 weeks
• 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

Locations

Country	Name	City	State
United States	Center for Tobacco Research and Intervention	Madison	Wisconsin
United States	Center for Tobacco Research and Intervention	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52	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	7-day point prevalence	No