NCT01243203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 8, 2017

Status Verified

November 1, 2013

Enrollment Period

3 years

First QC Date

November 16, 2010

Last Update Submit

May 4, 2017

Conditions

Smoking

Keywords

Smoking, surgery, Anesthesia, quit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Placebo

PLACEBO COMPARATOR

patient will receive placebo pills

Drug: Champix

Interventions

ChampixDRUG

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)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Department of Anesthesai

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (1)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 18, 2010

Study Start

November 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

May 8, 2017

Record last verified: 2013-11

Locations

CA(1)