Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00356993 |
| Other study ID # |
81/2005 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2005 |
| Est. completion date |
March 30, 2018 |
Study information
| Verified date |
November 2021 |
| Source |
Centre for Addiction and Mental Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
