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Smoking Cessation Program in the Preadmission Clinic: The Use of a Teachable Moment

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01243203
First received: November 16, 2010
Last updated: December 17, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Smoking
Drug: Champix

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:


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

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

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

Enrollment: 300
Study Start Date: November 2007
Study Completion Date: November 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
patient will receive placebo pills
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01243203

Locations
Canada, Ontario
University Health Network, Department of Anesthesai
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
  More Information

No publications provided

Responsible Party: Dr. Frances Chung, Staff Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01243203     History of Changes
Other Study ID Numbers: GA30517W
Study First Received: November 16, 2010
Last Updated: December 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Smoking, surgery, Anesthesia, quit

ClinicalTrials.gov processed this record on November 25, 2014