A Double Blind Randomized Placebo Controlled Study, for Smoking Cessation in Preadmission Clinic. the Use of a Teachable Moment
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date).
Study Overview
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."
Detailed Description
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. We 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.
The intervention program for this study will be primarily based on the smoking cessation guidelines endorsed by the Department of Family and Community Medicine, University of Toronto. The study research staffs (including the research coordinator) will be trained in accordance with these guidelines and the reading material provided will also be based on the same guidelines. The counseling skills of the coordinator will be reviewed every 3 months to ensure minimal variability. The coordinator will also be involved in regular meetings to address difficult situations and scenarios. They will also be provided checklists for all interventions to ensure that all components are covered uniformly for each patient. For each patient, the research staff who interviews the patient at the beginning will be the same during the whole treatment and follow-up period.
Interventions in Preadmission:
Demographic and personal chrematistics of the patients including age, sex, average number of cigarette smoked per day will be recorded. Patients will then receive a questionnaire based on Prochaska and DiClemente's Stages of Change Model to determine whether they were precontemplating, contemplating, preparing for or actively engaged in smoking cessation. In order to have the baseline smoking status, urinary cotinine and expired-air carbon monoxide (COE) will be measured in all patients at the preadmission clinic.
All patients will receive two 15 minute face to face standard counseling sessions by the research coordinator. First counseling will be done in preadmission. Counseling will include provision of advice to quit smoking and obtaining information regarding smoking behavior and skill building supplemented with standard printed materials. The patients will be informed of benefits of even short term abstinence before surgery. The target quit date (TQD) for all patients will be set up as 24 hours before surgery as surgical patients are routinely required to be abstinent at the time of surgery. The patients will be instructed to initiate the medication (or placebo) exactly one week before TQD. The whole treatment period is 12 weeks which includes 1- week titration as follows:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Smoking counseling, Varenicline
Intervention: varenicline (Drug)
Smoking counseling, Placebo
Intervention: Smoking counseling (Behavioral)
Smoking counseling, Placebo
Intervention: placebo (Drug)
Smoking counseling, Varenicline
Intervention: Smoking counseling (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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.(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)