CClinicalTrials.gg
Sign In
CompletedNCT00962988Updated Aug 10, 2026Results posted

Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease

A Phase 4 interventional study of Cost-Free Pharmacotherapy Group and Prescription Only Group in Cerebrovascular Disorders and Smoking Cessation, sponsored by Ottawa Heart Institute Research Corporation. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Ottawa Heart Institute Research Corporation · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
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.

02

Conditions studied

  • Cerebrovascular Disorders
  • Smoking Cessation

Keywords

  • Cerebrovascular disease
  • stroke
  • Transient Ischemic Attack
  • smoking cessation
  • Pharmacotherapy
03

In context

Cerebrovascular Disorders

374 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.

This study's enrollment of 194 is above the median of 110 across 214 interventional studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 179 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
194 participants (actual)

Study arms

  • Experimental
    Cost-Free Group

    Drug: Cost-Free Pharmacotherapy Group

  • Other
    Prescription Only Group

    Other: Prescription Only Group

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.

    Also known as: Nicotine Patch, Champix, Chantix, Wellbutrin

  • 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

06

What researchers measure

Primary outcomes

  1. Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date.

    Time frame: 52 weeks

Secondary outcomes

  1. Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date.

    Time frame: 26 weeks

  2. Self-reported 7-day Point Prevalence Abstinence at 12 Week Followup

    Time frame: 12 weeks

  3. Verified 7-day Point Prevalence Abstinence at 26 Week Follow-up

    Time frame: 26 weeks

  4. Verified 7-day Point Prevalence Abstinence at 52 Week Follow-up

    Time frame: 52 weeks

07

Results

Posted Aug 10, 2026
Limitations and caveats
Results were inconclusive. The intended sample size was not reached due to many smokers not being ready to quit smoking within 30 days of their stroke prevention clinic visit.

Participant flow

Participant flow — Overall Study
MilestoneCost-Free GroupPrescription Only Group
Started9995
Analyzed9793
Completed6852
Not completed3143

Outcome measures

PrimaryBiochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date.
Time frame:
52 weeks
Reported as:
Count of participants · Participants
Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date.
ParticipantsCost-Free GroupPrescription Only Group
Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 52 Following the Target Quit Date.1513
SecondaryBiochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date.
Time frame:
26 weeks
Reported as:
Count of participants · Participants
Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date.
ParticipantsCost-Free GroupPrescription Only Group
Biochemically Confirmed (Exhaled CO < 10 Ppm) of Self-reported Continuous Abstinence From Weeks 12 to 26 Following the Target Quit Date.1815
SecondarySelf-reported 7-day Point Prevalence Abstinence at 12 Week Followup
Time frame:
12 weeks
Reported as:
Count of participants · Participants
Self-reported 7-day Point Prevalence Abstinence at 12 Week Followup
ParticipantsCost-Free GroupPrescription Only Group
Self-reported 7-day Point Prevalence Abstinence at 12 Week Followup3725
SecondaryVerified 7-day Point Prevalence Abstinence at 26 Week Follow-up
Time frame:
26 weeks
Reported as:
Count of participants · Participants
Verified 7-day Point Prevalence Abstinence at 26 Week Follow-up
ParticipantsCost-Free GroupPrescription Only Group
Verified 7-day Point Prevalence Abstinence at 26 Week Follow-up2117
SecondaryVerified 7-day Point Prevalence Abstinence at 52 Week Follow-up
Time frame:
52 weeks
Reported as:
Count of participants · Participants
Verified 7-day Point Prevalence Abstinence at 52 Week Follow-up
ParticipantsCost-Free GroupPrescription Only Group
Verified 7-day Point Prevalence Abstinence at 52 Week Follow-up2216

Adverse events

Collected over Baseline to 52 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cost-Free Group1/99 (1%)10/99 (10.1%)0/99 (0%)
Prescription Only Group1/95 (1.1%)12/95 (12.6%)0/95 (0%)
Most frequent serious events
Most frequent serious events
EventCost-Free GroupPrescription Only Group
Other, requiring hospitalizationGeneral disorders6/998/95
Cardiac revascularizationCardiac disorders3/992/95
Stroke, worsening stroke, or trans ischemic attackGeneral disorders2/992/95
DeathGeneral disorders1/991/95
Carotid endarterectomyGeneral disorders1/991/95
Angina (Stable or Unstable)Cardiac disorders0/991/95
Deep vein thrombosisGeneral disorders1/991/95
Myocardial infarctionCardiac disorders1/990/95
Implantable cardioverter-defibrillator insertionCardiac disorders1/990/95

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cost-Free GroupPrescription Only GroupTotal
Mean55.5 ± 9.756.7 ± 10.756.1 ± 10.2
Sex: Female, Male
Sex: Female, Male(Participants)Cost-Free GroupPrescription Only GroupTotal
Female493988
Male5056106
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Cost-Free GroupPrescription Only GroupTotal
Count of participants——0
Years of formal education
Years of formal education(Years)Cost-Free GroupPrescription Only GroupTotal
Mean12.1 ± 2.612.1 ± 2.412.1 ± 2.5
Body Mass Index
Body Mass Index(kg/m^2)Cost-Free GroupPrescription Only GroupTotal
Mean27.4 ± 5.728.1 ± 6.327.7 ± 6.0
Reason for stroke prevention clinic referral
Reason for stroke prevention clinic referral(Participants)Cost-Free GroupPrescription Only GroupTotal
Trans-ischemic attack454691
Stroke5449103
History of depression
History of depression(Participants)Cost-Free GroupPrescription Only GroupTotal
Count of participants283159
History of Diabetes
History of Diabetes(Participants)Cost-Free GroupPrescription Only GroupTotal
Count of participants342256

7 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Hamilton Health Sciences -Stroke Prevention Clinic
    Hamilton, Ontario L8L 2X2, Canada
  • The Ottawa Hospital - Stroke Prevention Clinic
    Ottawa, Ontario K1Y 4E9, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00962988
Lead sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Heart and Stroke Foundation of Ontario
Responsible party
Sponsor
First posted
Aug 20, 2009
Start date
Dec 2009
Primary completion
Apr 2015
Completion
Apr 2015
Results posted
Aug 10, 2026
Last update
Aug 10, 2026

Study contacts

Grant Stotts, MD
principal investigator · The Ottawa Hospital
Andrew Pipe, MD
study chair · Ottawa Heart Institute Research Corporation
Sophia Papadakis, MHA
study chair · Ottawa Heart Institute Research Corporation
Debbie Aitken, RN BScN
study chair · Ottawa Heart Institute Research Corporation
Kerri-Anne Mullen, MSc
study chair · Ottawa Heart Institute Research Corporation
Sophia Gocan, RN BScN
study chair · The Ottawa Hospital
Mary Ann Laplante, RN BScN
study chair · The Ottawa Hospital
Robert Reid, MBA PhD
principal investigator · Ottawa Heart Institute Research Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cerebrovascular Disorders→

Other studies from this sponsor

Ottawa Heart Institute Research Corporation

Start the discussion