Clinical trial NCT00962988: Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease
Official title: Efficacy and Cost-effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebrovascular Disorders
Smoking Cessation
Keywords: Cerebrovascular disease
stroke
Transient Ischemic Attack
smoking cessation
Pharmacotherapy
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2009-08-20
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 group or a cost-free (CF) pharmacotherapy experimental group. Participants assigned to the prescription only usual care group will be asked to have their prescription for smoking cessation pharmacotherapy filled at their own cost at their local community pharmacy. Participants assigned to the cost-free pharmacotherapy group will be provided with a 12-week supply of NRT, or a 12-week supply of bupropion or varenicline. The pharmacotherapy will be provided by the research nurse to the patient immediately. All participants will receive identical advice regarding smoking from the attending neurologist, nurse counseling for smoking cessation, and follow-up tracking and telephone-based support for up to 26 weeks after the target quit date. Non-treatment follow-up will continue to week 52 after the target quit date.

Eligibility 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)

Primary outcomes:
measure: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence from weeks 12 to 52 following the target quit date.
timeFrame: 52 weeks
Secondary outcomes:
measure: The secondary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence from weeks 12 to 26 following the target quit date.
timeFrame: 26 weeks
measure: The total costs of smoking cessation treatment will be tracked over the duration of the study to determine the cost-effectiveness of providing cost-free pharmacotherapy for smoking cessation versus a prescription only.
timeFrame: 3 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences -Stroke Prevention Clinic
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Stroke Prevention Clinic
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Grant Stotts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Andrew Pipe, MD
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Sophia Papadakis, MHA
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Debbie Aitken, RN BScN
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Kerri-Anne Mullen, MSc
role: STUDY_CHAIR
affiliation: The Ottawa Hospital
name: Sophia Gocan, RN BScN
role: STUDY_CHAIR
affiliation: The Ottawa Hospital
name: Mary Ann Laplante, RN BScN
role: STUDY_CHAIR
affiliation: Ottawa Heart Institute Research Corporation
name: Robert Reid, MBA PhD
role: PRINCIPAL_INVESTIGATOR
References: