Smoking Cessation Program in the Preadmission Clinic

Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: Smoking cessation counselling group; Other: Control group:

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T2S8
      • Toronto Western Hospital, Department of Aneshtesia
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital, Department of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pre-surgery counseling for quit smoking	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)	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative complications	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).	3 months after surgery

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Pfizer
• Investigators: Principal Investigator: Frances Chung, FRCPC, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: March 21, 2011
• First Posted (Estimate): March 22, 2011

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: anesthesia; Smoking; surgery; champix; quit
• Other Study ID Numbers: WS836526