Status:
COMPLETED
Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Conditions:
Cerebrovascular Disorders
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ov...
Detailed Description
Smokers with Transient Ischemic Attack (TIA) or stroke attending a Stroke Prevention Clinic and willing to quit smoking will be randomly assigned (1:1) to either a prescription only (PO) usual care gr...
Eligibility Criteria
Inclusion
- Patient is a current daily smoker (one cigarette per day in the month preceding the visit to the Stroke Prevention Clinic)
- Patient has been diagnosed with TIA or stroke at any point in time
- Patient is able, in the opinion of the neurologist, to comprehend and participate in the smoking cessation interventions
- Patient is 18 years of age or older
- Patient is willing to set a quit date
- Patient willing to travel to study centre for follow-up visits
- Patient is willing to provide informed consent
Exclusion
- Patient is unable to understand English or French
- Patient is not willing to use pharmacotherapy to quit
- Patient has been using smoking cessation medication for more than 6 weeks directly prior to clinic visit or hospital admission.
- Patient is pregnant, lactating or planning to become pregnant during the study period
- 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)
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00962988
Start Date
December 1 2009
End Date
April 1 2015
Last Update
March 10 2022
Active Locations (2)
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1
Hamilton Health Sciences -Stroke Prevention Clinic
Hamilton, Ontario, Canada, L8L 2X2
2
The Ottawa Hospital - Stroke Prevention Clinic
Ottawa, Ontario, Canada, K1Y 4E9