Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease
NCT00959972 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2011-04-29
Summary
The purpose of this study is to determine if a new drug, varenicline, for smoking cessation is more effective than the standard nicotine replacement therapy aide currently used, "the patch" among smokers hospitalized with coronary heart disease.
Conditions
Interventions
- DRUG
-
Varenicline
Participants randomized to varenicline will be administered 0.5 mg/day for 3 days, 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for an additional 11 weeks.
- DRUG
-
Transdermal Nicotine Patch
Participants randomized to NRT will apply the patch immediately on the first day and each morning thereafter for 12 weeks. Doses of NRT will be 21 mg/day for the first 6 weeks, 14 mg/day for 4 weeks, then 7 mg/day for 2 weeks.
Sponsors & Collaborators
-
Heart and Stroke Foundation of Ontario
collaborator OTHER -
Ottawa Heart Institute Research Corporation
lead OTHER
Principal Investigators
-
Robert Reid, PhD MBA · Ottawa Heart Institute Research Corporation
-
Andrew Pipe, MD · Ottawa Heart Institute Research Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2010-11-30
- Completion
- 2010-11-30
Countries
- Canada
Study Locations
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