An interventional study of Nicotine Replacement Therapy and behavioural intervention in Smoking, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
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.
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.
Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nicotine Replacement Therapy plus Behavioural Intervention
Drug: Nicotine Replacement Therapy · Behavioral: behavioural intervention
transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
Also known as: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge
Smoking cessation counselling, relapse prevention strategies
Count of Participants Not Smoking
7-day point prevalence of abstinence at 6 months post treatment
Time frame: 6 months post treatment
Count of Participants Not Smoking
7-day point prevalence of abstinence at 12 months post treatment
Time frame: 12 months post treatment
| Milestone | NRT + Behavioural Support |
|---|---|
| Started | 6009 |
| Completed | 2088 |
| Not completed | 3921 |
7-day point prevalence of abstinence at 6 months post treatment
| Participants | NRT + Behavioural Support |
|---|---|
| Count of Participants Not Smoking | 766 |
7-day point prevalence of abstinence at 12 months post treatment
| Participants | NRT + Behavioural Support |
|---|---|
| Count of Participants Not Smoking | 147 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NRT + Behavioural Support | 0/6,009 (0%) | 0/6,009 (0%) | 0/6,009 (0%) |
| Age, Continuous(years) | NRT + Behavioural Support |
|---|---|
| Mean | 47.6 ± 11.9 |
| Sex: Female, Male(Participants) | NRT + Behavioural Support |
|---|---|
| Female | 3201 |
| Male | 2799 |
| Race and Ethnicity Not Collected(Participants) | NRT + Behavioural Support |
|---|
| Cigarettes per day (cpd)(Participants) | NRT + Behavioural Support |
|---|---|
| 1-9 cigarettes | 6 |
| 10-14 cigarettes | 358 |
| 15-19 cigarettes | 337 |
| 20-24 cigarettes | 493 |
| 25+ cigarettes | 888 |
| No response | 6 |
| Age started to smoke daily(years) | NRT + Behavioural Support |
|---|---|
| Mean | 17.3 ± 4.8 |
| Age first smoked(years) | NRT + Behavioural Support |
|---|---|
| Mean | 14.2 ± 5.1 |
| Number of Quit Attempts in past year(Participants) | NRT + Behavioural Support |
|---|---|
| 0 quit attempt | 3058 |
| 1 quit attempt | 2328 |
| 2 quit attempts | 378 |
| Importance of Quitting(Participants) | NRT + Behavioural Support |
|---|---|
| 1-least important thing to do | 22 |
| 2 | 10 |
| 3 | 13 |
| 4 | 14 |
| 5 | 70 |
| 6 | 66 |
| 7 | 217 |
| 8 | 797 |
| 9 | 802 |
| 10- the most important thing to do | 3969 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health