Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Research Aims

The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy:

1. Helps smokers with Transient Ischemic Attack (TIA) or stroke to quit smoking over the long-term, compared to simply providing a prescription for these medications;

2. Is a more cost-effective alternative to providing a prescription only for these medications in this high risk population.

Hypotheses to be Tested

The hypotheses to be tested include the following:

1. The CO-validated continuous abstinence rate at weeks 26 and 52 following a target quit date will be at least 10% higher for the cost-free smoking cessation pharmacotherapy intervention group compared to the prescription only usual care group;

2. Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness (i.e., cost/quit) than providing a prescription only.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborator: Heart and Stroke Foundation of Ontario
• Treatments: Bupropion; Nicotine

Criteria

Inclusion Criteria:

1. Patient is a current daily smoker (one cigarette per day in the month preceding the visit to the Stroke Prevention Clinic)

2. Patient has been diagnosed with TIA or stroke at any point in time

3. Patient is able, in the opinion of the neurologist, to comprehend and participate in the smoking cessation interventions

4. Patient is 18 years of age or older

5. Patient is willing to set a quit date

6. Patient willing to travel to study centre for follow-up visits

7. Patient is willing to provide informed consent

Exclusion Criteria:

1. Patient is unable to understand English or French

2. Patient is not willing to use pharmacotherapy to quit

3. Patient has been using smoking cessation medication for more than 6 weeks directly prior to clinic visit or hospital admission.

4. Patient is pregnant, lactating or planning to become pregnant during the study period

5. Patient has contraindication(s) to all of the following smoking cessation medications:

• Nicotine replacement therapy (allergy to adhesive, serious cardiac arrhythmias (e.g., tachycardia), vasospastic disease (e.g., Buerger's disease, Prinzmetal's variant angina)

• Bupropion (history of seizure disorder or head trauma; presently taking Wellbutrin; previous reaction to bupropion/Zyban/Wellbutrin; pre-existing or current eating disorder; taking anti-depressants, antipsychotics, corticosteroids, MAO inhibitors, theophylline, cocaine or diet pills; taking a quinalone antibiotic (e.g., ciprofloxacin, levoflozacin); currently using oral hypoglycemic product or insulin; severe hepatic impairment; CNS tumour; and

• Varenicline (renal failure; use of cimetidine; previous reaction to varenicline)