Overview

Smoking Cessation Program in the Preadmission Clinic

Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a randomized, double-blind, placebo-controlled clinical trial which evaluates the efficacy of preoperative smoking counseling and varenicline (a medication approved by Health Canada and FDA for quitting smoking) to provide long term smoking cessation (i.e., abstinence for at least one year) in surgical patients. The primary hypothesis is as follows: "A significant percentage of surgical patients will be receptive to smoking cessation interventions in the pre-admission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment." The secondary hypothesis is as follows: "Patients who receive interventions but do not quit smoking will have reduced number of cigarettes consumed/day or improved their readiness to quit smoking at 24 and 52 weeks after starting the treatment."
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Health Network, Toronto
Collaborator:
Pfizer
Treatments:
Varenicline
Criteria
Inclusion Criteria:

- patients who are assessed in pre-admission clinic and scheduled for elective surgical
procedures within the next 8 to 30 days

- patients should be over 18 yrs of age

- patients should have smoked an average 10 cigarettes/day or more during the previous
year and had no period of smoking abstinence longer than 3 months in the past year

Exclusion Criteria:

- current pregnancy (or willingness to be pregnant within the next year after the start
of the medication)

- current breastfeeding

- major depression, panic disorder, psychosis, or bipolar disorder within the prior year

- use of nicotine replacement or bupropion within the previous 3 months cardiovascular
disease within the past 6 months

- a serious or unstable disease within the past 6 months

- drug or alcohol abuse or dependence within the past year

- use of tobacco products other than cigarettes or marijuana use within the previous
month

- participating in any other studies

- patients who cannot understand English or have any form of cognitive impairment