Smoking Cessation Program in the Preadmission Clinic

NCT00937508 | Unknown Phase 4 DMC

• 2 other identifiers: 07-0585-AEProtocol# in Pfizer: GA30517W
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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."

Conditions

Smoking

Keywords

smoking; quitting; varenicline; preoperative; long term abstinence

Outcome Measures

Primary Outcomes (1)

• Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date).

  52 weeks after starting the treatment

Secondary Outcomes (5)

• Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date).

  24 weeks after starting the treatment.

• Number of cigarettes consumed per day over the past week prior to the assessment date.

  52 weeks after starting the treatment

• Number of cigarettes consumed per day over the past week prior to the assessment date.

  24 weeks after starting the treatment

• "stage of change" (determined by Prochaska and DiClemente's Model)

  52 weeks after starting the treatment

• Total prevalence of drug-related adverse events

  after treatment unitl one month after the end of treatment

Study Arms (2)

Smoking counseling, Placebo

PLACEBO COMPARATOR

Behavioral: Smoking counseling; Drug: placebo

Smoking counseling, Varenicline

EXPERIMENTAL

Behavioral: Smoking counseling; Drug: varenicline

Interventions

Smoking counseling BEHAVIORAL

Preoperative and postoperative counseling sessions provided by a trained smoking counselor along with placebo.

Also known as: counseling for smoking cessation

Smoking counseling, Placebo; Smoking counseling, Varenicline

varenicline DRUG

varenicline (an approved medication for smoking cessation)

Also known as: Champix, Chanitx

Smoking counseling, Varenicline

placebo DRUG

sugar pill without any active medication

Also known as: sugar pill (control)

Smoking counseling, Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Pfizer: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (2)

• Streck JM, Rigotti NA, Livingstone-Banks J, Tindle HA, Clair C, Munafo MR, Sterling-Maisel C, Hartmann-Boyce J. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2024 May 21;5(5):CD001837. doi: 10.1002/14651858.CD001837.pub4.

  PMID: 38770804 DERIVED

• 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: 37142273 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Counseling; Varenicline; Sugars

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Carbohydrates

Study Officials

• Frances Chung, FRCPC

  Anesthesia Department, Toronto Western Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances Chung, FRCPC

CONTACT

416-519-0132; frances.chung@uhn.on.ca

Amir Abrishami, MD

CONTACT

amir_abrishami@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: June 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: June 1, 2011
• Last Updated: April 8, 2010

Record last verified: 2010-01

Locations

CA (1)