This trial is active, not recruiting.

Condition smoking
Treatments smoking cessation counselling group, control group:
Sponsor University Health Network, Toronto
Collaborator Pfizer
Start date December 2010
End date August 2017
Trial size 296 participants
Trial identifier NCT01320462, WS836526


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Counselling, Pharmacotherapy and Smokers Help Line
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
Brief informatin about quitting and smokers help line
control group:
Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.

Primary Outcomes

pre-surgery counseling for quit smoking
time frame: 1 year after surgery

Secondary Outcomes

perioperative complications
time frame: 3 months after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line
Principal investigator Frances Chung, FRCPC
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.