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Last Updated: Nov 25th, 2007 - 10:09:00

                                                                                                                              

Stop Smoking Therapy for Ontario Patients


By Clinical Trials


Aug 26, 2006, 09:08


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Stop Smoking Therapy for Ontario Patients (STOP) Phase I

This study is currently recruiting patients.
Verified by Centre for Addiction and Mental Health July 2006

Sponsors and Collaborators: Centre for Addiction and Mental Health
Pfizer Consumer Health Care
Ontario Ministry of Health and Long Term Care
Information provided by: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00356993

Purpose

20% of Ontarians smoke. There was a decline in smoking prevalence from 1995 but it has remained unchanged since 2002. This rate of smoking cessation has not kept up with the rest of Canada. A new strategy is necessary to increase the number of smokers making quit attempts and to increase the odds of quitting long term.The goal of this study is to evaluate the methods and effectiveness of providing nicotine replacement (NRT) to Ontario smokers. The study will develop an evidence-based protocol for providing NRT, provide faculty development on combining pharmacotherapy with behavioural interventions and will provide an evaluation framework to inform future coverage models.
Condition Intervention
Smoking
 Drug: nicotine replacement
 Behavior: behavioural intervention

MedlinePlus related topics:  Smoking

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title: The STOP (Stop Smoking Therapy for Ontario Patients) Study: The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers.

Further study details as provided by Centre for Addiction and Mental Health:
Primary Outcomes: Smoking cessation outcome measures; Health care utilization measures; Smoker and provider satisfaction
Expected Total Enrollment:  10000

Study start: October 2005;  Expected completion: October 2007

According to the US Surgeon General's Report (1988), there are immediate, intermediate and long-term benefits to health from quitting smoking. For example, there is a 50% reduction in coronary heart disease risk in 12 months and the risk of a stroke is reduced to that of a nonsmoker 5-15 years after quitting. (US Surgeon General's Report, 1990, p.vi). In a systematic assessment of the value of clinical preventive services recommended by the US Preventive Services Task Force, smoking cessation treatment for adults was one of the highest-ranked services in terms of its cost effectiveness and its potential to reduce the burden of disease. Most smoking cessation interventions cost less per year of life saved than most widely accepted medical practices. For example, cost-effectiveness analysis of the implementation of the Agency for Healthcare Research and Quality (AHRQ) guidelines show costs of $4,113 per life-year saved, in 2001 prices compared to annual mammography for women aged 40 to 49 years, which costs $71,751 in 2001 prices, and hypertension screening for men aged 40 years, which costs $27,117 in 2001 prices. Therefore, smoking cessation services have been referred to as the "gold standard" for comparing the cost effectiveness of other healthcare interventions. Although some studies have shown high costs from increased healthcare utilization in the first year after quitting smoking due to illness (Martinson, 2003), most studies demonstrate that smokers who quit eventually have significantly lower healthcare utilization than continuing smokers (Fishman, 2003; Warner, 2003) Thus, for healthcare organizations such as the Ontario Health Insurance Plan, implementing smoking cessation services will likely result in a relatively quick return on investment. Both the intensity and duration of behavioural interventions are associated with sustained remission in smoking. The addition of pharmacotherapy doubles the odds of quitting successfully. However, many smokers face barriers in accessing pharmacotherapy. The provision of free pharmacotherapy has the potential to help a substantial number of smokers to quit. A study by Curry et al, 1998, evaluated smokers who were willing to sign up for a cessation-support program under various degrees of coverage for either the program or nicotine replacement therapy (NRT). 10% of Smokers with full coverage were likely to attempt to quit as opposed to 2.5% with partial coverage. Therefore, the USHHS guidelines call for the coverage of these medications. Research has shown that coverage for tobacco dependence treatments can enhance not only the rate of quit attempts but also long-term abstinence for smokers (Levy & Friend, 2002; Schauffler, McMenamin, Olson, Boyce-Smith, Rideout, & Kamil, 2001). On average, the odds ratio of quitting at one year was 1.6 for those given free NRT. Therefore, some insurers, both public and private, reimburse patients for stop smoking medications. However, a study by Boyle et al 2002, found that simply including the medication in an insurance plan did not increase quit rates or utilization of medications. Adequate precautions must be taken to ensure that free pharmacotherapy is distributed in conjunction with behavioural interventions to be successful and to be used by those smokers most likely to benefit from pharmacotherapy.Pharmacotherapy can be very expensive if provided to all smokers. However, not all smokers want to quit or require medications to quit (McDonald, 2003). Most smokers use about 2-3 weeks of pharmacotherapy when not combined with behavioural interventions (Pierce, 2002). About 0.05% of smokers looking to quit will seek specialized care. Moreover, if we assume that 70% of current tobacco users (Approximately 1.6 million) in Ontario will try to quit in a given year and that 10% ( i.e. 169,000) of these individuals would qualify for and seek reimbursement for 10 weeks of therapy at $30/week, then the total estimated cost will be about $50 million! This is clearly not fundable and therefore a comprehensive strategy combined with some rational use of pharmacotherapy is necessary.Hypotheses:

1. The provision of free NRT will increase quit attempts in Ontario smokers 2. The provision of free NRT will increase long-term quit rates (>/= 6 months) in Ontario smokers.

3. Smokers who quit smoking using NRT will have reduced health care costs after the first year of treatment.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Subjects must be Ontario residents with valid OHIP cards
  • Older than or equal to 18 years of age
  • Current daily/near daily smokers who smoke >10 cigarettes per day
  • Smoked more than 100 cigarettes in their lifetime
  • Willing to provide informed consent to link Personal Health information and utilization of health care services

Exclusion Criteria:

  • Allergic to adhesive
  • Intolerant to Nicotine Replacement Therapy
  • Medical contraindication as determined by the attending physician of the patient or study physician

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00356993

Peter Selby, MD      416-535-8501  Ext. 6859    peter_selby@camh.net
Laurie Zawertailo       laurie_zawertailo@camh.net

Canada, Ontario
      Centre for Addiction and Mental Health, Toronto,  Ontario,  M5S 2S1,  Canada; Recruiting
Peter Selby, MD  416-535-8501  Ext. 6859    peter_selby@camh.net 
Peter Selby, MD,  Principal Investigator
Laurie Zawertailo,  Sub-Investigator


 

Study chairs or principal investigators

Peter Selby, MD,  Principal Investigator,  Centre for Addiction and Mental Health   

More Information

Study ID Numbers:  81/2005
Last Updated:  July 25, 2006
Record first received:  July 25, 2006
ClinicalTrials.gov Identifier: 
NCT00356993
Health Authority: Canada: Health Canada
 
Smoking: 'Why Do I Smoke?' Quiz  (American Academy of Family Physicians)
Smoking and Pregnancy  (American Lung Association)
Smoking among Women: Cardiovascular Disease and Stroke  (Centers for Disease Control and Prevention)
JAMA Patient Page: Smoking Cessation  (American Medical Association)
You Can Control Your Weight as You Quit Smoking  (National Institute of Diabetes and Digestive and Kidney Diseases)
Quit Smoking Action Plan  (American Lung Association)
Products to Help You Stop Smoking  (Mayo Foundation for Medical Education and Research)
I Quit: What to Do When You're Sick of Smoking, Chewing, or Dipping  (Centers for Disease Control and Prevention)
Smoking Cessation in Recovering Alcoholics  (American Academy of Family Physicians)
Guide to Quitting Smoking  (American Cancer Society)
ClinicalTrials.gov: Smoking  (National Institutes of Health)
Questions and Answers about Smoking Cessation  (National Cancer Institute)
Health Consequences of Smoking on the Human Body  (Centers for Disease Control and Prevention)
Smoking: Don't Let It Steer You Wrong  (American Academy of Family Physicians)
FDA Approves New Drug for Smoking Cessation  (Food and Drug Administration)
Smoking: Do I Want to Quit?  (American Academy of Family Physicians)
Quit to Live: How and Why to Quit Smoking Today  (Centers for Disease Control and Prevention)
Cigarette Smoking among Adults—United States, 2004  (Centers for Disease Control and Prevention)
How Can I Quit Smoking?  (American Heart Association) Links to PDF File.
Quitting Still Best Strategy for Reducing Risks of Smoking  (American Cancer Society)
Prevention and Cessation of Cigarette Smoking (PDQ): Control of Tobacco Use  (National Cancer Institute)
Why It's Important for Women to Quit  (National Women's Health Information Center)
 


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smoking, smoking cessation, stop smoking, quit smoking