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

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.

Conditions

• Cerebrovascular Disorders
• Smoking Cessation

Interventions

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.

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

Sponsors & Collaborators

• Heart and Stroke Foundation of Ontario

  collaborator OTHER

• Ottawa Heart Institute Research Corporation

  lead OTHER

Principal Investigators

• Grant Stotts, MD · The Ottawa Hospital

• Andrew Pipe, MD · Ottawa Heart Institute Research Corporation

• Sophia Papadakis, MHA · Ottawa Heart Institute Research Corporation

• Debbie Aitken, RN BScN · Ottawa Heart Institute Research Corporation

• Kerri-Anne Mullen, MSc · Ottawa Heart Institute Research Corporation

• Sophia Gocan, RN BScN · The Ottawa Hospital

• Mary Ann Laplante, RN BScN · The Ottawa Hospital

• Robert Reid, MBA PhD · Ottawa Heart Institute Research Corporation

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2015-04-30

Completion

2015-04-30

Countries

• Canada

Study Locations