Back to results

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

Primary Purpose

Cerebrovascular Disorders, Smoking Cessation

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Cost-Free Pharmacotherapy Group

Prescription Only Group

About this trial

This is an interventional prevention trial for Cerebrovascular Disorders focused on measuring Cerebrovascular disease, stroke, Transient Ischemic Attack, smoking cessation, Pharmacotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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:
- 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)

Sites / Locations

Hamilton Health Sciences -Stroke Prevention Clinic
The Ottawa Hospital - Stroke Prevention Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cost-Free Group

Prescription Only Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00962988

First Posted

August 18, 2009

Last Updated

February 24, 2022

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Heart and Stroke Foundation of Ontario

1. Study Identification

Unique Protocol Identification Number

NCT00962988

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Research Aims 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebrovascular Disorders, Smoking Cessation

Keywords

Cerebrovascular disease, stroke, Transient Ischemic Attack, smoking cessation, Pharmacotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cost-Free Group

Arm Type

Experimental

Arm Title

Prescription Only Group

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Cost-Free Pharmacotherapy Group

Other Intervention Name(s)

Nicotine Patch, Champix, Chantix, Wellbutrin

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Prescription Only Group

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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: 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)

Overall Study Officials: