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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: March 23, 2012
Last verified: March 2012
History of Changes
Results First Received: February 15, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Smoking
Interventions: Drug: nicotine replacement therapy
Behavioral: behavioural interventions

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group 1 Open-label NRT + counseling

Participant Flow:   Overall Study
    Group 1  
STARTED     1767  
COMPLETED     884  
NOT COMPLETED     883  



  Baseline Characteristics
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Reporting Groups
  Description
Group 1 Open-label NRT + counseling

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
 		  1767  
Age  
[units: participants]
 		 
<=18 years     7  
Between 18 and 65 years     1654  
>=65 years     106  
Age  
[units: years]
Mean ± Standard Deviation 		  45.0  ± 12.7  
Gender  
[units: participants]
 		 
Female     997  
Male     770  
Region of Enrollment  
[units: participants]
 		 
Canada     1767  



  Outcome Measures
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1.  Primary:   Smoking Cessation   [ Time Frame: 6 months after end of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Smoking Cessation   [ Time Frame: 12 months after end of treatment ]
  Show Outcome Measure 2

3.  Secondary:   Smoker and Provider Satisfaction   [ Time Frame: 3, 6 month follow-up ]
  Show Outcome Measure 3

4.  Secondary:   Healthcare Utilization Measures   [ Time Frame: 12-month follow-up ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Many participants could not be reached 6 and 12 months after treatment to complete the follow-up questionnaires. Data pertaining to the secondary outcomes measures, smoker and provider satisfaction and healthcare utilization, were not collected.  


Results Point of Contact:  
Name/Title: Co-Investigator
Organization: Centre for Addiction and Mental Health
phone: 416-535-8501 ext 7422
e-mail: laurie_zawertailo@camh.net


No publications provided


Responsible Party: Dr. Peter Selby, 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: March 23, 2012
Health Authority: Canada: Health Canada