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SmokingSTOPNCT00352781

Stop Smoking Therapy for Ontario Patients

A study testing nicotine replacement therapy and behavioural intervention in people with Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Approximately 2 million Ontarians are current smokers. While smoking rates have declined over the past 25 years, these rates have remained constant since 2002. The rate of smoking cessation in Ontario has not kept up with the rest of Canada. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking
What is being tested?
nicotine replacement therapy and behavioural intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,767 participants
Where
1 siteCanada
Study dates
Jul 2006to Aug 2009
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be current residents of Ontario.
  • Older than or equal to 18 years of age.
  • Current daily smokers who smoke 10 or more cigarettes per day for at least 3 months.
  • Has smoked more than 100 cigarettes in their lifetime.

Who cannot join

  • Varenicline treatment, current.
  • Intolerant to nicotine replacement therapy (NRT)
  • Have a medical condition that would make participation medically hazardous as determined by the list of contraindications for NRT outlined in the Compendium of Pharmaceuticals and Specialties (CPS) and the NRT package insert, including a heart attack in the past two (2) weeks, life-threatening arrhythmias, severe or worsening angina pectoris, recent cerebro-vascular incident (past two (2) weeks)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5S 2S1

Other trials in Canada

About this study

Official title: The STOP (Stop Smoking Therapy for Ontario Patients) Study: The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers PHASE II

Approximately 2 million Ontarians are current smokers. While smoking rates have declined over the past 25 years, these rates have remained constant since 2002. The rate of smoking cessation in Ontario 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 over the long term.

The overall goal of the Stop Smoking Therapy for Ontario Patients (STOP) Study is to evaluate the methods and effectiveness of providing nicotine replacement therapy (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.

The goal for this phase of the STOP study is to provide faculty development on combining pharmacotherapy with behavioural interventions. This will be achieved by partnering with Public Health Units across Ontario who have established smoking cessation clinics but do not have the finances in place to offer NRT to their clients at a subsidized rate or free of charge. Cost has been shown to be a significant barrier to the access and use of NRT in individuals trying to quit smoking. However, combining pharmacotherapy with behavioural interventions may be more effective than either alone. Therefore, we hypothesize that providing NRT free of charge to clients enrolled in a smoking cessation clinic will be more effective for smoking cessation than behavioural interventions alone.

Read the detailed description

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 United States Health \& Human Services 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.
Conditions
Smoking
Being tested
nicotine replacement therapy, behavioural intervention
Keywords
nicotine replacement therapy, smoking cessation
Medical subject headings
Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nicotine replacement therapyDrug

    Also called Nicoderm

    nicotine transdermal patches as per product monograph

  • behavioural interventionBehavioural

    Smoking cessation counselling and relapse prevention

Study groups in NCT00352781
Study groupRoleWhat they receive
Nicotine Replacement + Behaviour TherapyExperimentalNicotine Replacement Therapy as per monograph \& behavioural intervention
Receives: Drug: nicotine replacement therapy; Behavioral: behavioural intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking Cessation

    7-day point prevalence of abstinence

    Measured: 6 months after end of treatment

Secondary outcomes (1)
  1. Smoking Cessation

    7-day point prevalence of abstinence

    Measured: 12 months after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionJan 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,767 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352781
Sponsor's protocol ID
064/2006
Acronym
STOP
Status last verified
Dec 2017
First submitted
13 Jul 2006
Last updated
28 Dec 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing nicotine replacement therapy and behavioural intervention in people with Smoking, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Cessation (time frame: 6 months after end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.

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