Phase 2
N=60
An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT00835900 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
May 2017
Primary outcome: Primary: Change in Smoking Behavior — -6.3; -3.2 Change in Cigarettes Per Day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- varenicline (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Smoking Behavior |
-6.3; -3.2 | — |
| SECONDARY Rates of Smoking Cessation. |
17; 11 | — |
Summary
The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.
Eligibility Criteria
Inclusion Criteria
- currently smoking at least 15 cigarettes daily
- in good health
- able to read and speak English fluently
- have a home telephone and plan to reside in Western New York for 6 months
- willing to make quit attempt
- signed informed consent
- who planned quit attempt.
Exclusion Criteria
- serious medical condition
- depression or mental health condition requiring treatment in the past year
- history of panic disorder, psychosis, bipolar disorder
- alcohol or drug abuse in the past year
- use of tobacco products other than cigarettes
- current use of other cessation pharmacotherapies
- pregnancy/planned pregnancy.
Data sourced from ClinicalTrials.gov (NCT00835900). 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.