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

Smoking Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243203
• Other study ID #: GA30517W
• Status: Completed
• Phase: N/A
• First received: November 16, 2010
• Last updated: May 4, 2017
• Start date: November 2007
• Est. completion date: November 2011

Study information

• Verified date: November 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

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)

Locations

Country	Name	City	State
Canada	University Health Network, Department of Anesthesai	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years
Secondary	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.		2 years