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

NCT00962988 | Completed Phase 4 DMC

• 1 other identifier: HIPRC-6749
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

Brief Summary

Research Aims The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy:

1. 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. 2.Is a more cost-effective alternative to providing a prescription only for these medications in this high risk population.
3. 3.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;
4. 4.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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (2)

• 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.

  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.

  3 years

Study Arms (2)

Cost-Free Group

EXPERIMENTAL

Drug: Cost-Free Pharmacotherapy Group

Prescription Only Group

OTHER

Other: Prescription Only Group

Interventions

Cost-Free Pharmacotherapy Group DRUG

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

Cost-Free Group

Prescription Only Group OTHER

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

Prescription Only Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (2)

Hamilton Health Sciences -Stroke Prevention Clinic

Hamilton, Ontario, L8L 2X2, Canada

Location

The Ottawa Hospital - Stroke Prevention Clinic

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Cerebrovascular Disorders; Smoking Cessation; Stroke; Ischemic Attack, Transient

Interventions

Tobacco Use Cessation Devices; Varenicline; Bupropion

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Health Behavior; Behavior; Brain Ischemia

Intervention Hierarchy (Ancestors)

Therapeutics; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Propiophenones; Ketones; Organic Chemicals

Study Officials

• Grant Stotts, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

• Robert Reid, MBA PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 20, 2009
• Study Start: December 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 10, 2022

Record last verified: 2022-02

Locations

CA (2)