N/A
N=1,767
Stop Smoking Therapy for Ontario Patients
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT00352781 ↗Enrolled (actual)
1,767
Serious AEs
0.1%
Results posted
Apr 2012
Primary outcome: Primary: Smoking Cessation — 29 percentage of participants abstinent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nicotine replacement therapy (Drug); behavioural intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre for Addiction and Mental Health
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Cessation |
26 | — |
| SECONDARY Smoking Cessation |
26 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00352781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.