Cerebrovascular Disorders, Smoking Cessation
Conditions
Keywords
Cerebrovascular disease, stroke, Transient Ischemic Attack, smoking cessation, Pharmacotherapy
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.
Interventions
DRUGCost-Free Pharmacotherapy Group
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. Patients smoking 10 cigarettes or less will be prescribed 7mg/24hours for 12 weeks. Those who smoke 11- 20 cigarettes per day will be prescribed 14 mg/24 hours for 8 weeks and then nicotine patch 7mg for 4 weeks. Those smoking ≥ 20 cigarettes per day will be prescribed 21 mg/daily for 6 weeks and then nicotine patch 14mg/daily for 4 weeks and then nicotine patch 7 mg/daily for 2 weeks. For patients who are prescribed varenicline, they will start the medication 8 days before the quit date using the following regime: Days 1-3: 0.5mg once/day; Days 4-7: 0.5 mg BID; Day 8-12 weeks 1.0 mg twice daily. For patients who are prescribed bupropion, they will start the medication 8 days before the quit date using the following regime: Days 1-3: 150 mg daily (in the morning); Day 4-30: 150 mg BID for 3 months.
OTHERPrescription Only 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
Sponsors
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date. | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date. | 26 weeks |
| Self-reported 7-day Point Prevalence Abstinence at 12 Week Followup | 12 weeks |
| Verified 7-day Point Prevalence Abstinence at 26 Week Follow-up | 26 weeks |
| Verified 7-day Point Prevalence Abstinence at 52 Week Follow-up | 52 weeks |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORGrant Stotts, MD
The Ottawa Hospital
STUDY_CHAIRAndrew Pipe, MD
Ottawa Heart Institute Research Corporation
STUDY_CHAIRSophia Papadakis, MHA
Ottawa Heart Institute Research Corporation
STUDY_CHAIRDebbie Aitken, RN BScN
Ottawa Heart Institute Research Corporation
STUDY_CHAIRKerri-Anne Mullen, MSc
Ottawa Heart Institute Research Corporation
STUDY_CHAIRSophia Gocan, RN BScN
The Ottawa Hospital
STUDY_CHAIRMary Ann Laplante, RN BScN
The Ottawa Hospital
PRINCIPAL_INVESTIGATORRobert Reid, MBA PhD
Ottawa Heart Institute Research Corporation
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 10.7 |
| Body Mass Index | 28.1 kg/m^2 STANDARD_DEVIATION 6.3 |
| Cigarettes per day | 16.5 cigarettes per day STANDARD_DEVIATION 7.5 |
| Confidence in ability to quit smoking scale | 3.4 Score STANDARD_DEVIATION 1.2 |
| Fagerstrom nicotine dependence score | 4.5 score STANDARD_DEVIATION 2.2 |
| Has insurance coverage for cessation medication | 20 Participants |
| History of depression | 28 Participants |
| History of Diabetes | 56 Participants |
| Importance of quitting smoking scale | 4.6 score STANDARD_DEVIATION 0.9 |
| Quit attempts in past year | 1.3 Number of quit attempts STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | 0 Participants |
| Reason for stroke prevention clinic referral Stroke | 54 Participants |
| Reason for stroke prevention clinic referral Trans-ischemic attack | 46 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 50 Participants |
| Years of formal education | 12.1 Years STANDARD_DEVIATION 2.6 |
| Years smoked | 37.1 years STANDARD_DEVIATION 12.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 99 | 1 / 95 |
| other Total, other adverse events | 0 / 99 | 0 / 95 |
| serious Total, serious adverse events | 10 / 99 | 12 / 95 |
Outcome results
None listed