Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00962988|
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : April 15, 2015
The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy:
- 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;
- 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:
- 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;
- Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness (i.e., cost/quit) than providing a prescription only.
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Disorders Smoking Cessation||Drug: Cost-Free Pharmacotherapy Group Other: Prescription Only Group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Cost-effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
|Experimental: Cost-Free Group||
Drug: Cost-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.
|Prescription Only Group||
Other: Prescription 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
- 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. [ Time Frame: 52 weeks ]
- 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. [ Time Frame: 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. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962988
|Hamilton Health Sciences -Stroke Prevention Clinic|
|Hamilton, Ontario, Canada, L8L 2X2|
|The Ottawa Hospital - Stroke Prevention Clinic|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Principal Investigator:||Grant Stotts, MD||The Ottawa Hospital|
|Study Chair:||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|
|Principal Investigator:||Robert Reid, MBA PhD||Ottawa Heart Institute Research Corporation|