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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT00959972
First received: August 14, 2009
Last updated: April 27, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
Drug: Varenicline
Drug: Transdermal Nicotine Patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease: a Pilot Randomized Trial

Resource links provided by NLM:


Further study details as provided by Ottawa Heart Institute Research Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes will include adherence to prescribed pharmacotherapy measured at 12 weeks and measures of nicotine withdrawal and self-efficacy. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: April 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Nicotine Patch
  • Patch
  • Nicoderm
  • NRT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959972

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Robert Reid, PhD MBA Ottawa Heart Institute Research Corporation
Study Chair: Andrew Pipe, MD Ottawa Heart Institute Research Corporation
  More Information

Publications:
Responsible Party: Robert Reid, PhD, MBA, University of Ottawa Heart Insitute
ClinicalTrials.gov Identifier: NCT00959972     History of Changes
Other Study ID Numbers: HIPRC-6551
Study First Received: August 14, 2009
Last Updated: April 27, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Heart Institute Research Corporation:
Varenicline
transdermal nicotine patch
cardiovascular disease
prevention
coronary heart disease
Smoking cessation

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Nicotine
Varenicline
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014