Smoking Cessation Program in the Preadmission Clinic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00937508
First received: July 9, 2009
Last updated: April 7, 2010
Last verified: January 2010
  Purpose

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."


Condition Intervention Phase
Smoking
Behavioral: Smoking counseling
Drug: varenicline
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Randomized Placebo Controlled Study, for Smoking Cessation in Preadmission Clinic. the Use of a Teachable Moment

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: 24 weeks after starting the treatment. ] [ Designated as safety issue: Yes ]
  • Number of cigarettes consumed per day over the past week prior to the assessment date. [ Time Frame: 52 weeks after starting the treatment ] [ Designated as safety issue: No ]
  • Number of cigarettes consumed per day over the past week prior to the assessment date. [ Time Frame: 24 weeks after starting the treatment ] [ Designated as safety issue: No ]
  • "stage of change" (determined by Prochaska and DiClemente's Model) [ Time Frame: 52 weeks after starting the treatment ] [ Designated as safety issue: No ]
  • Total prevalence of drug-related adverse events [ Time Frame: after treatment unitl one month after the end of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 290
Study Start Date: June 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Smoking counseling, Placebo Behavioral: Smoking counseling
Preoperative and postoperative counseling sessions provided by a trained smoking counselor along with placebo.
Other Name: counseling for smoking cessation
Drug: placebo
sugar pill without any active medication
Other Name: sugar pill (control)
Experimental: Smoking counseling, Varenicline Behavioral: Smoking counseling
Preoperative and postoperative counseling sessions provided by a trained smoking counselor along with placebo.
Other Name: counseling for smoking cessation
Drug: varenicline
varenicline (an approved medication for smoking cessation)
Other Name: Champix, Chanitx

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937508

Contacts
Contact: Frances Chung, FRCPC 416-519-0132 ext 5433 frances.chung@uhn.on.ca
Contact: Amir Abrishami, MD amir_abrishami@yahoo.com

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Frances Chung, FRCPC    416-603-5800    frances.chung@uhn.on.ca   
Principal Investigator: Frances Chung, FRCPC         
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
Investigators
Principal Investigator: Frances Chung, FRCPC Anesthesia Department, Toronto Western Hospital, University of Toronto
  More Information

No publications provided

Responsible Party: Dr. Frances Chung, Anesthesia Department, Toronto Western Hospital, University Health Network
ClinicalTrials.gov Identifier: NCT00937508     History of Changes
Other Study ID Numbers: 07-0585-AE, Protocol# in Pfizer: GA30517W
Study First Received: July 9, 2009
Last Updated: April 7, 2010
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
smoking
quitting
varenicline
preoperative
long term abstinence

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014