Smoking Cessation Program in the Preadmission Clinic

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01320462
First received: March 21, 2011
Last updated: December 17, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Smoking
Drug: Smoking cessation counselling group
Other: Control group:

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • pre-surgery counseling for quit smoking [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]

    In order to determine the prevalence of abstinence in long-term follow up (4, 12, 24 and 52 weeks), patients will be asked the following questions:

    • Have you been abstinent from smoking for the past four weeks? (4-week abstinence)
    • Do you currently smoke cigarettes everyday? (point prevalence)
    • Have you been abstinent from smoking since the last time you quit smoking? (continuous abstinence)


Secondary Outcome Measures:
  • perioperative complications [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
    Secondary outcome measures that will be studied are as follows: The changes in the number of cigarettes consumed per day or 'stage of change' at 4, 12, 24 and 52 weeks after the initial assigned target quit date. The incidence of perioperative complications (until 30 days after surgery) as well as medication-related adverse events (and serious adverse events) will also be recorded (only those who in the smoking-cessation program).


Estimated Enrollment: 296
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smoking cessation group
Counselling, Pharmacotherapy and Smokers Help Line
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
Control group
Brief informatin about quitting and smokers help line
Other: Control group:
Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01320462

Locations
Canada, Ontario
Toronto Western Hospital, Department of Aneshtesia
Toronto, Ontario, Canada, M5T2S8
Mount Sinai Hospital, Department of Anesthesia
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
Investigators
Principal Investigator: Frances Chung, FRCPC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Frances Chung, Staff Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01320462     History of Changes
Other Study ID Numbers: WS836526
Study First Received: March 21, 2011
Last Updated: December 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Smoking
quit
surgery
anesthesia
champix

ClinicalTrials.gov processed this record on August 20, 2014