Phase 4
Completed N=101
Long-term Varenicline Treatment for Smoking Cessation
Source: ClinicalTrials.gov NCT00828113 ↗Enrolled (actual)
101
Serious AEs
3.0%
Results posted
Jul 2012
Primary outcomePrimary: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 — 10; 11 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 |
10; 11 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00828113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.