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Trial record 1 of 1 for:    NCT01243203
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Smoking Cessation Program in the Preadmission Clinic: The Use of a Teachable Moment

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ClinicalTrials.gov Identifier: NCT01243203
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE November 16, 2010
First Posted Date  ICMJE November 18, 2010
Last Update Posted Date May 8, 2017
Study Start Date  ICMJE November 2007
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2010)
A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2010)
Patients who receive interventions but do not quit smoking will have reduced number of cigarettes consumed /day or improved "stage of change" (determined by Prochaska and DiClemente's Model) at 24 and 52 weeks after starting the treatment. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation Program in the Preadmission Clinic: The Use of a Teachable Moment
Official Title  ICMJE Not Provided
Brief Summary The Objective of this study is to introduce a practically feasible multifaceted intervention in the preadmission clinic to help reduce smoking in preoperative surgical patients. The investigators aim to study the effectiveness of such a program in promoting positive change in smoking behavior among patients before surgery. The forced abstinence enforced on patients during hospital stay for their surgery can also be used to help smokers remain tobacco free long term. A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Smoking
Intervention  ICMJE Drug: Champix
Days 1 - 3: 0.5 mg once daily (1 table each day) Days 4 - 7: 0.5 mg twice daily (1 in the morning and 1 in the evening) Days 8 - 12 weeks 1.0 mg twice daily (1 in the morning and 1 in the evening)
Study Arms  ICMJE Placebo Comparator: Placebo
patient will receive placebo pills
Intervention: Drug: Champix
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2010)
300
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The investigators will recruit patients who are assessed in preadmission clinic and scheduled for elective surgical procedures within the next 8 to 30 days.
  • Patients should be 18 yrs of age, 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, 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;
  • and 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 will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01243203
Other Study ID Numbers  ICMJE GA30517W
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Frances Chung, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account University Health Network, Toronto
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP