Smoking Cessation Program in the Preadmission Clinic

NCT ID: NCT01320462

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2017-04-30

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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Smoking cessation group

Counselling, Pharmacotherapy and Smokers Help Line

Group Type: EXPERIMENTAL

Smoking cessation counselling group

Intervention Type: DRUG

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

Group Type: OTHER

Control group:

Intervention Type: OTHER

Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.

Interventions

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

Intervention Type: DRUG

Control group:

Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frances Chung

Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frances Chung, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto Western Hospital, Department of Aneshtesia

Toronto, Ontario, Canada

Mount Sinai Hospital, Department of Anesthesia

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

WS836526

Identifier Type: -

Identifier Source: org_study_id