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Completed

NCT Number: NCT01320462

Smoking Cessation Program in the Preadmission Clinic

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Department of Anesthesia, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smoking cessation counselling group

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:

Other

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

Primary outcomes

  1. pre-surgery counseling for quit smoking

    Time frame: 1 year after surgery

    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 outcomes

  1. perioperative complications

    Time frame: 3 months after surgery

    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).

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2011
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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