Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease

Phase 4

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: Transdermal Nicotine Patch; Drug: Varenicline

• Registration Number: NCT00959972
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief 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.

Detailed Description

Quitting smoking is the single most effective intervention or treatment to reduce death rates in patients with coronary heart disease (CHD) who smoke. At the University of Ottawa Heart Institute (Ottawa, Canada), an institutional program is in place to ensure that staff consistently identify and document tobacco use status and treatment is offered to every smoker admitted to the Institute. Currently, nicotine replacement therapy (NRT) is the principal medication used in the program. Recently, a new medication, varenicline, was approved for smoking cessation in Canada. Varenicline appears be the most effective medication for cessation currently available. To date, most published studies of varenicline have been funded by the manufacturer and there are no published studies reporting how well it works in smokers hospitalized with heart disease.

This study involves sixty current smokers hospitalized at the UOHI for CHD. Consenting smokers will be randomly assigned to receive varenicline for 12 weeks or transdermal NRT for 12 weeks. Participants will also complete a two-page questionnaire inquiring about smoking history and previous attempts to quit, level of nicotine dependence, symptoms of nicotine withdrawal and self-efficacy with respect to quitting smoking. All participants will receive identical in-hospital counseling, self-help materials and follow-up support. The nurse specialists will also contact the participants by phone 3, 14, 30 and 50 days post-hospital discharge to check the patient's smoking status, assess the risk of relapse, and identify any adverse events that have occurred. The study will follow up with participants at 12 and 26 weeks post randomization asking about their smoking status (biochemically confirmed with a carbon monoxide monitor), adherence to prescribed medication, self-efficacy with respect to quitting smoking, nicotine withdrawal and smoking cessation resources used post-discharge.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• smoking at least 10 cigarettes/day in the month prior to admission
• patient has been diagnosed with acute coronary syndrome (includes patients admitted for unstable angina or acute myocardial infarction), elective percutaneous coronary intervention, or coronary artery bypass surgery at any point in time
• motivated to stop smoking
• geographically available for follow-up visits (i.e., live within 1 hour of the study centre)

Exclusion Criteria

• have been using NRT, Zyban (or Wellbutrin), and/or Champix for more than 72 hours
• have serious cardiac arrhythmias (e.g., tachycardia), vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina)
• have severe renal impairment or are on dialysis
• unable to read and understand English
• patient is pregnant or breastfeeding or planning on becoming pregnant during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdermal Nicotine Patch	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.
Varenicline	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.

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26.	26 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will include adherence to prescribed pharmacotherapy measured at 12 weeks and measures of nicotine withdrawal and self-efficacy.	26 weeks

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada