Recruiting

Smoking Cessation

Sponsor:

University Health Network, Toronto

Code:

NCT00937508

Conditions

Smoking

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smoking counseling

varenicline

placebo

Study Details

Brief 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."

Conditions

Smoking

Study ID

NCT00937508

Start date

Jun, 2008

Status verified date

Jan, 2010

Completion date

Jun, 2011

Anticipated

Primary completion date

Jul, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

290 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Smoking counseling, Placebo

experimental: Smoking counseling, Varenicline

Interventions

Smoking counseling

Preoperative and postoperative counseling sessions provided by a trained smoking counselor along with placebo.

varenicline

varenicline (an approved medication for smoking cessation)

placebo

sugar pill without any active medication

Primary outcome measure

  • Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). [ Time Frame: 52 weeks after starting the treatment ]

Central Contacts and Locations

Central contacts

Frances Chung, FRCPC

416-519-0132frances.chung@uhn.on.ca

Amir Abrishami, MD

amir_abrishami@yahoo.com

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Frances Chung, FRCPC

416-603-5800frances.chung@uhn.on.ca

Principal Investigator:

Frances Chung, FRCPC

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 8, 2010

Last verified

Jan, 2010

Keywords

  • smoking
  • quitting
  • varenicline
  • preoperative
  • long term abstinence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2010-04-08.