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

This study is currently recruiting participants.
Verified January 2013 by University of Ottawa Heart Institute
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr Robert Reid, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00962988
First received: August 18, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.

Condition Intervention Phase
Cerebrovascular Disorders
Smoking Cessation
 Drug: Cost-Free Pharmacotherapy Group
Other: Prescription Only Group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy and Cost-effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ottawa Heart Institute:

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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 562
Study Start Date: December 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cost-Free Group 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 Names:
  • Nicotine Patch
  • Champix
  • Chantix
  • Wellbutrin
Prescription Only Group 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962988

Contacts
Contact: Ashley Armstrong, MA (c) 613-798-5555 ext 19345 aarmstrong@ottawaheart.ca
Contact: Lisa McDonnell, MSc 613-798-5555 ext 19095 lmcdonnell@ottawaheart.ca

Locations
Canada, Ontario
Hamilton Health Sciences -Stroke Prevention Clinic Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Gail Mackenzie, RN MScN     905-527-4322 ext 46814     mackenzg@HHSC.CA    
Contact: Ashley Armstrong, MA (c)     613-798-5555 ext 19345     aarmstrong@ottawaheart.ca    
Principal Investigator: D Sahlas, MD            
The Ottawa Hospital - Stroke Prevention Clinic Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Ashley Armstrong, MA (c)     613-798-5555 ext 19345     aarmstrong@ottawaheart.ca    
Principal Investigator: Mukul Sharma, MD            
Sponsors and Collaborators
University of Ottawa Heart Institute
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Mukul Sharma, MD The Ottawa Hospital
Study Chair: Andrew Pipe, MD University of Ottawa Heart Institute
Study Chair: Sophia Papadakis, MHA University of Ottawa Heart Institute
Study Chair: Debbie Aitken, RN BScN University of Ottawa Heart Institute
Study Chair: Kerri-Anne Mullen, MSc University of Ottawa Heart Institute
Study Chair: Sophia Gocan, RN BScN The Ottawa Hospital
Study Chair: Mary Ann Laplante, RN BScN The Ottawa Hospital
Principal Investigator: Robert Reid, MBA PhD University of Ottawa Heart Institute
  More Information

No publications provided

Responsible Party: Dr Robert Reid, Associate Director, Minto Prevention and Rehabilitation Centre, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00962988     History of Changes
Other Study ID Numbers: HIPRC-6749
Study First Received: August 18, 2009
Last Updated: January 14, 2013
Health Authority: Canada: Research Ethics Board

Keywords provided by University of Ottawa Heart Institute:
Cerebrovascular disease
stroke
Transient Ischemic Attack
smoking cessation
Pharmacotherapy

Additional relevant MeSH terms:
Cerebrovascular Disorders
Smoking
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Habits
Nicotine
Ganglionic Stimulants
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013