SmokingNCT00356993
Phase I Study: Stop Smoking Therapy for Ontario Patients (STOP)
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.
Trial summary
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. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,009 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to 30 Mar 2018
- 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 Ontario residents
- Older than or equal to 18 years of age
- Current daily smokers who smoke >10 cigarettes per day
- Smoked more than 100 cigarettes in their lifetime
Who cannot join
- Current treatment with Varenicline
- Allergic to adhesive
- Intolerant to Nicotine Replacement Therapy
- Medical contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The STOP (Stop Smoking Therapy for Ontario Patients) Study: The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers.
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.
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 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.Hypothesis:
The provision of free NRT will increase long-term quit rates (>/= 6 months) in Ontario smokers.
- 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 transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
behavioural interventionBehavioural
Smoking cessation counselling, relapse prevention strategies
| Study group | Role | What they receive |
|---|---|---|
| NRT + Behavioural Support | Experimental | Nicotine Replacement Therapy plus 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.
Count of Participants Not Smoking
7-day point prevalence of abstinence at 6 months post treatment
Measured: 6 months post treatment
Secondary outcomes (1)
Count of Participants Not Smoking
7-day point prevalence of abstinence at 12 months post treatment
Measured: 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startOct 2005
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 6,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Principal investigator, Peter Selby, Centre for Addiction and Mental Health
- Investigators
- Peter Selby, MD, MHSc, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356993
- Sponsor's protocol ID
- 81/2005
- Status last verified
- Nov 2021
- First submitted
- 25 Jul 2006
- Last updated
- 30 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STOP (Stop Smoking Therapy for Ontario Patients) Study: The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers.
- ClinicalTrials.gov ID
- NCT00356993
- Acronym / sponsor ID
- 81/2005
- Conditions
- Smoking
- Keywords
- nicotine replacement therapy, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,009 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Oct 2005
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 27 Jul 2006 (estimated)
- Results
- Posted 2 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.Hypothesis:
The provision of free NRT will increase long-term quit rates (>/= 6 months) in Ontario smokers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NRT + Behavioural Support | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: behavioural interventionNicotine Replacement Therapy plus Behavioural Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be Ontario residents
- Older than or equal to 18 years of age
- Current daily smokers who smoke >10 cigarettes per day
- Smoked more than 100 cigarettes in their lifetime
Key exclusion criteria (4 listed)
- Current treatment with Varenicline
- Allergic to adhesive
- Intolerant to Nicotine Replacement Therapy
- Medical contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement TherapyAlso: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozengetransdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge | Drug | NRT + Behavioural Support |
| behavioural interventionSmoking cessation counselling, relapse prevention strategies | Behavioural | NRT + Behavioural Support |
Primary outcome
Count of Participants Not Smoking
Time frame: 6 months post treatment
7-day point prevalence of abstinence at 6 months post treatment
1 secondary outcome
Count of Participants Not Smoking
Time frame: 12 months post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
- click for more information on the study: The STOP (Stop Smoking Therapy for Ontario Patients) Study: The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Selby, MD, MHSc principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
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 4 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 30 Nov 2021. 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 2 May 2019). 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?
Count of Participants Not Smoking (time frame: 6 months post 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 30 Nov 2021.