Cerebrovascular DisordersPhase 4NCT00962988
Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease
A Phase 4 study testing Cost-Free Pharmacotherapy Group and Prescription Only Group in people with Cerebrovascular Disorders and Smoking Cessation, run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Disorders, Smoking Cessation
- What is being tested?
- Cost-Free Pharmacotherapy Group and Prescription Only Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2009to Apr 2015
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton Health Sciences -Stroke Prevention Clinic
Hamilton, Ontario, L8L 2X2
The Ottawa Hospital - Stroke Prevention Clinic
Ottawa, Ontario, K1Y 4E9
About this study
Official title: Efficacy and Cost-effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease
Research Aims
The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy:
Read more
- 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.
Read the 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.
- Conditions
- Cerebrovascular Disorders, Smoking Cessation
- Being tested
- Cost-Free Pharmacotherapy Group, Prescription Only Group
- Keywords
- Cerebrovascular disease, stroke, Transient Ischemic Attack, smoking cessation, Pharmacotherapy
- Medical subject headings
- Cerebrovascular Disorders, Smoking Cessation, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cost-Free Pharmacotherapy GroupDrug
Also called Nicotine Patch, Champix, Chantix, Wellbutrin
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 GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cost-Free Group | Experimental | Not described Receives: Drug: Cost-Free Pharmacotherapy Group |
| Prescription Only Group | Other | Not described Receives: Other: Prescription Only Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date.
Measured: 52 weeks
Secondary outcomes (4)
Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date.
Measured: 26 weeks
Self-reported 7-day Point Prevalence Abstinence at 12 Week Followup
Measured: 12 weeks
Verified 7-day Point Prevalence Abstinence at 26 Week Follow-up
Measured: 26 weeks
Verified 7-day Point Prevalence Abstinence at 52 Week Follow-up
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Sponsor
- Investigators
- Grant Stotts, MD, Principal investigator, The Ottawa HospitalAndrew Pipe, MD, Study chair, Ottawa Heart Institute Research CorporationSophia Papadakis, MHA, Study chair, Ottawa Heart Institute Research CorporationDebbie Aitken, RN BScN, Study chair, Ottawa Heart Institute Research CorporationKerri-Anne Mullen, MSc, Study chair, Ottawa Heart Institute Research CorporationSophia Gocan, RN BScN, Study chair, The Ottawa HospitalMary Ann Laplante, RN BScN, Study chair, The Ottawa HospitalRobert Reid, MBA PhD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962988
- Sponsor's protocol ID
- HIPRC-6749
- Status last verified
- Feb 2022
- First submitted
- 18 Aug 2009
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes