Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Varenicline; Transdermal Nicotine Patch
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Champix; Chantix; Nicotine Patch; Patch; Nicoderm; NRT
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Varenicline; transdermal nicotine patch; cardiovascular disease; prevention; coronary heart disease; Smoking cessation