Smoking Cessation Program in the Preadmission Clinic

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NCT01320462

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Study Location
Toronto Western Hospital, Department of Aneshtesia
Toronto, Ontario, M5T2S8, Canada
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients who smoke more than 10 cigarettes per day for more than 1 year

- And had no period of smoking abstinence longer than 3 months in the past year.

- Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients > 18 years of age

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients unwilling or unable to give informed consent


- Patients who are pregnant and breast feeding


- Patients with any psychiatric disorder


- Patients who used nicotine replacement / bupropion within previous 3 months


- Cardiovascular disease within the past 6 months


- Any serious or unstable disease within the past 6 months


- Drug or alcohol abuse within the past year.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Smoking Cessation Program in the Preadmission Clinic
Official Title  ICMJE Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line
Brief Summary

Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates

Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Smoking
Intervention  ICMJE
  • Drug: Smoking cessation counselling group
    The smoking-cessation program has three components; structured preoperative counseling, pharmacotherapy with varenicline for three months, and referral to the quit line (Smokers' Helpline) for proactive telephone counseling and follow up
  • Other: Control group:
    Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.
Study Arms  ICMJE
  • Experimental: Smoking cessation group
    Counselling, Pharmacotherapy and Smokers Help Line
    Intervention: Drug: Smoking cessation counselling group
  • Control group
    Brief informatin about quitting and smokers help line
    Intervention: Other: Control group:
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2011)		296
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who smoke more than 10 cigarettes per day for more than 1 year
  • And had no period of smoking abstinence longer than 3 months in the past year.
  • Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients > 18 years of age

Exclusion Criteria:

  • Patients unwilling or unable to give informed consent
  • Patients who are pregnant and breast feeding
  • Patients with any psychiatric disorder
  • Patients who used nicotine replacement / bupropion within previous 3 months
  • Cardiovascular disease within the past 6 months
  • Any serious or unstable disease within the past 6 months
  • Drug or alcohol abuse within the past year.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01320462
Other Study ID Numbers  ICMJE WS836526
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Frances Chung, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Frances Chung, FRCPCUniversity Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP