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

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ClinicalTrials.gov Identifier: NCT00959972

Recruitment Status : Completed

First Posted : August 17, 2009

Last Update Posted : April 29, 2011

Sponsor:

Collaborator:

Heart and Stroke Foundation of Ontario

Information provided by:

Ottawa Heart Institute Research Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease	Drug: Varenicline Drug: Transdermal Nicotine Patch	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	April 2009
Actual Primary Completion Date :	November 2010
Actual Study Completion Date :	November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex Varenicline Varenicline tartrate

U.S. FDA Resources

Arms and Interventions

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: Nicotine Patch Patch Nicoderm NRT

Outcome Measures

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 ]

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959972

Locations

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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

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

More Information

Publications:

Pipe A. Smoking. Can J Cardiol. 1999 Dec;15 Suppl G:77G-80G. Review.

Critchley J, Capewell S. Smoking cessation for the secondary prevention of coronary heart disease. Cochrane Database Syst Rev. 2003;(4):CD003041. Review. Update in: Cochrane Database Syst Rev. 2004;(1):CD003041.

Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001837. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD001837.

Reid RD, Pipe AL, Quinlan B. Promoting smoking cessation during hospitalization for coronary artery disease. Can J Cardiol. 2006 Jul;22(9):775-80.

Meine TJ, Patel MR, Washam JB, Pappas PA, Jollis JG. Safety and effectiveness of transdermal nicotine patch in smokers admitted with acute coronary syndromes. Am J Cardiol. 2005 Apr 15;95(8):976-8.

Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55.

Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.

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Responsible Party:	Robert Reid, PhD, MBA, University of Ottawa Heart Insitute
ClinicalTrials.gov Identifier:	NCT00959972
Other Study ID Numbers:	HIPRC-6551
First Posted:	August 17, 2009 Key Record Dates
Last Update Posted:	April 29, 2011
Last Verified:	April 2011

Keywords provided by Ottawa Heart Institute Research Corporation:


Varenicline transdermal nicotine patch cardiovascular disease	prevention coronary heart disease Smoking cessation

Additional relevant MeSH terms:

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

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