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Long-term Varenicline Treatment for Smoking Cessation

NCT00828113 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2015-11-20

Study results available
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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.

Conditions

  • Smoking

Interventions

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-09-30
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00828113 on ClinicalTrials.gov