CClinicalTrials.gg
CompletedNCT00356993Updated Nov 30, 2021Results posted

Phase I Study: Stop Smoking Therapy for Ontario Patients (STOP)

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

Phase
Not applicable
Study type
Interventional
Enrollment
6,009
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Smoking

Keywords

  • nicotine replacement therapy
  • smoking cessation
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Current treatment with Varenicline
  • Allergic to adhesive
  • Intolerant to Nicotine Replacement Therapy
  • Medical contraindications
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6,009 participants (actual)

Study arms

  • Experimental
    NRT + Behavioural Support

    Nicotine Replacement Therapy plus Behavioural Intervention

    Drug: Nicotine Replacement Therapy · Behavioral: behavioural intervention

Interventions

  • DrugNicotine Replacement Therapy

    transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge

    Also known as: transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge

  • Behavioralbehavioural intervention

    Smoking cessation counselling, relapse prevention strategies

06

What researchers measure

Primary outcomes

  1. Count of Participants Not Smoking

    7-day point prevalence of abstinence at 6 months post treatment

    Time frame: 6 months post treatment

Secondary outcomes

  1. Count of Participants Not Smoking

    7-day point prevalence of abstinence at 12 months post treatment

    Time frame: 12 months post treatment

07

Results

Posted May 2, 2019

Participant flow

Participant flow — Overall Study
MilestoneNRT + Behavioural Support
Started6009
Completed2088
Not completed3921

Outcome measures

PrimaryCount of Participants Not Smoking

7-day point prevalence of abstinence at 6 months post treatment

Time frame:
6 months post treatment
Reported as:
Count of participants · Participants
Count of Participants Not Smoking
ParticipantsNRT + Behavioural Support
Count of Participants Not Smoking766
SecondaryCount of Participants Not Smoking

7-day point prevalence of abstinence at 12 months post treatment

Time frame:
12 months post treatment
Reported as:
Count of participants · Participants
Count of Participants Not Smoking
ParticipantsNRT + Behavioural Support
Count of Participants Not Smoking147

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NRT + Behavioural Support0/6,009 (0%)0/6,009 (0%)0/6,009 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)NRT + Behavioural Support
Mean47.6 ± 11.9
Sex: Female, Male
Sex: Female, Male(Participants)NRT + Behavioural Support
Female3201
Male2799
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)NRT + Behavioural Support
Cigarettes per day (cpd)
Cigarettes per day (cpd)(Participants)NRT + Behavioural Support
1-9 cigarettes6
10-14 cigarettes358
15-19 cigarettes337
20-24 cigarettes493
25+ cigarettes888
No response6
Age started to smoke daily
Age started to smoke daily(years)NRT + Behavioural Support
Mean17.3 ± 4.8
Age first smoked
Age first smoked(years)NRT + Behavioural Support
Mean14.2 ± 5.1
Number of Quit Attempts in past year
Number of Quit Attempts in past year(Participants)NRT + Behavioural Support
0 quit attempt3058
1 quit attempt2328
2 quit attempts378
Importance of Quitting
Importance of Quitting(Participants)NRT + Behavioural Support
1-least important thing to do22
210
313
414
570
666
7217
8797
9802
10- the most important thing to do3969

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M5S 2S1, Canada
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00356993
Lead sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Ministry of Health and Long Term Care
Responsible party
Peter Selby (Chief, Addictions Program, Centre for Addiction and Mental Health) — Principal investigator
First posted
Jul 27, 2006
Start date
Oct 2005
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018
Results posted
May 2, 2019
Last update
Nov 30, 2021

Study contacts

Peter Selby, MD, MHSc
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion