Phase 4
Completed N=593
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
Source: ClinicalTrials.gov NCT00594204 ↗Enrolled (actual)
593
Serious AEs
2.2%
Results posted
Jul 2010
Primary outcomePrimary: Number of Participants With 4-week Continuous Abstinence — 209; 37 participants — p=<0.0001
Summary
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 4-week Continuous Abstinence |
209; 37 | <0.0001 sig |
| SECONDARY Number of Participants With Continuous Abstinence |
155; 26 | <0.0001 sig |
| SECONDARY Number of Participants With Seven-day Point Prevalence of Abstinence |
220; 45; 185; 38 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Current male or female cigarette smokers who are motivated to stop smoking.
- Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.
Exclusion Criteria
- Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
- Patients currently with depression or diagnosed with depression in past 12 months.
- Past or present history of psychosis, panic disorder, or bipolar disorder.
Data sourced from ClinicalTrials.gov (NCT00594204). 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.