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Stop Smoking Therapy for Ontario Patients (STOP)

This study has been completed.
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
Pfizer
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT00352781
First received: July 13, 2006
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Smoking Drug: nicotine replacement therapy Behavioral: behavioural intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The STOP (Stop Smoking Therapy for Ontario Patients) Study: The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers PHASE II

Resource links provided by NLM:


Further study details as provided by Dr. Peter Selby, Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Smoking Cessation [ Time Frame: 6 months after end of treatment ]
    7-day point prevalence of abstinence


Secondary Outcome Measures:
  • Smoking Cessation [ Time Frame: 12 months after end of treatment ]
    7-day point prevalence of abstinence


Enrollment: 1767
Study Start Date: July 2006
Study Completion Date: August 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine Replacement Therapy + Behavioural Intervention
Nicotine Replacement Therapy as per product monograph plus behavioural intervention
Drug: nicotine replacement therapy
nicotine transdermal patches as per product monograph
Other Name: Nicoderm
Behavioral: behavioural intervention
Smoking cessation counselling and relapse prevention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352781

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Ministry of Health and Long Term Care
Pfizer
Investigators
Principal Investigator: Peter Selby, MD, MHSc Centre for Addiction and Mental Health
  More Information

Additional Information:
Responsible Party: Dr. Peter Selby, Clinical Director, Addictions Program, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00352781     History of Changes
Other Study ID Numbers: 064/2006
Study First Received: July 13, 2006
Results First Received: February 15, 2012
Last Updated: August 15, 2013

Keywords provided by Dr. Peter Selby, Centre for Addiction and Mental Health:
nicotine replacement therapy
smoking cessation

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017