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
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
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
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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
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 June 13, 2013