Phase 2
Completed N=218
Efficacy of Varenicline in Ambivalent Smokers
Tobacco Use · Tobacco Use Cessation · Nicotine Dependence
Source: ClinicalTrials.gov NCT00595868 ↗
Enrolled (actual)
218
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: Number of Participants With a Quit Attempt — 55; 36 participants — p=0.06
Summary
The purpose of this study is to test whether Varenicline can help ambivalent smokers (those who are interested in quitting at some point in the future but have no current plans to quit) to reduce their smoking and eventually quit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Quit Attempt |
55; 36 | 0.06 |
| SECONDARY 7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million |
15; 8 | 0.10 |
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Able to get to research lab in Burlington, Vermont or Omaha, Nebraska
- Daily smoker
- Smoke at least 8 cigarettes per day
- No reduction in smoking in last 30 days
- No intention to quit in the next 30 days
- Never used Varenicline before
- Not currently using smoking cessation medications or nicotine replacement therapy
- Willing to use Varenicline for at least 2 weeks
- Fluent in English
Exclusion Criteria
- Cannot be currently pregnant or breastfeeding
- Kidney disease
- Frequent nausea
- On certain medications for asthma and/or depression
- Another household member in study
Data sourced from ClinicalTrials.gov (NCT00595868). 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.