Smoking Cessation Program in the Preadmission Clinic

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320462
• Other study ID #: WS836526
• Status: Completed
• Phase: N/A
• First received: March 21, 2011
• Last updated: May 4, 2017
• Start date: December 2010
• Est. completion date: April 2017

Study information

• Verified date: June 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital, Department of Anesthesia	Toronto	Ontario
Canada	Toronto Western Hospital, Department of Aneshtesia	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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