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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Ontario | OTHER |
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Research Aims
The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy:
Hypotheses to be Tested
The hypotheses to be tested include the following:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cost-Free Group | Experimental |
| |
| Prescription Only Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cost-Free Pharmacotherapy Group | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 26 weeks | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Grant Stotts, MD | The Ottawa Hospital | Principal Investigator |
| Andrew Pipe, MD | Ottawa Heart Institute Research Corporation | Study Chair |
| Sophia Papadakis, MHA | Ottawa Heart Institute Research Corporation | Study Chair |
| Debbie Aitken, RN BScN | Ottawa Heart Institute Research Corporation | Study Chair |
| Kerri-Anne Mullen, MSc | Ottawa Heart Institute Research Corporation | Study Chair |
| Sophia Gocan, RN BScN | The Ottawa Hospital | Study Chair |
| Mary Ann Laplante, RN BScN | The Ottawa Hospital | Study Chair |
| Robert Reid, MBA PhD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences -Stroke Prevention Clinic | Hamilton | Ontario | L8L 2X2 | Canada | ||
| The Ottawa Hospital - Stroke Prevention Clinic |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 27, 2026 | |
| Reset | Jun 23, 2026 |
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| Prescription Only Group | Other | 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 |
|
| 3 years |
| Ottawa |
| Ontario |
| K1Y 4E9 |
| Canada |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 27, 2026 | Jun 23, 2026 | |||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D016540 | Smoking Cessation |
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D002545 | Brain Ischemia |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D000068580 | Varenicline |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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