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

April 27, 2011 updated by: Ottawa Heart Institute Research Corporation

Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease: a Pilot Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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.
Other Names:
  • Champix
  • Chantix
Experimental: 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.
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.
Other Names:
  • Nicoderm
  • NRT
  • Patch
  • Nicotine Patch

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcomes will include adherence to prescribed pharmacotherapy measured at 12 weeks and measures of nicotine withdrawal and self-efficacy.
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

  • Study Chair: Andrew Pipe, MD, Ottawa Heart Institute Research Corporation
  • Principal Investigator: Robert Reid, PhD MBA, Ottawa Heart Institute Research Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

April 29, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPRC-6551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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