NCT00937508

A Double Blind Randomized Placebo Controlled Study, for Smoking Cessation in Preadmission Clinic. the Use of a Teachable Moment

Status unknown Phase 4 Last updated 7 April 2010

What this trial tests

Phase 4 trial testing Smoking counseling in Smoking in 290 participants. Status unknown.

Timeline

1 June 2008

Primary endpoint
1 July 2010

1 June 2011

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	290
Start date	1 June 2008
Primary completion	1 July 2010
Estimated completion	1 June 2011
Sites	1 location across Canada

Drugs / interventions tested

• Smoking counseling
• varenicline (varenicline) — full drug profile →
• placebo

Conditions studied

• Smoking — all drugs for Smoking →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Smoking. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date).
  Time frame: 52 weeks after starting the treatment

Sponsor's own description

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."

Publications & conference data

No peer-reviewed publications indexed yet for this trial.