Smoking Cessation Program in the Preadmission Clinic
This study is currently recruiting participants.
Verified June 2012 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01320462
First received: March 21, 2011
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates
Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.
| Condition | Intervention |
|---|---|
|
Smoking |
Drug: Smoking cessation counselling group Other: Control group: |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- pre-surgery counseling for quit smoking [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]
In order to determine the prevalence of abstinence in long-term follow up (4, 12, 24 and 52 weeks), patients will be asked the following questions:
- Have you been abstinent from smoking for the past four weeks? (4-week abstinence)
- Do you currently smoke cigarettes everyday? (point prevalence)
- Have you been abstinent from smoking since the last time you quit smoking? (continuous abstinence)
Secondary Outcome Measures:
- perioperative complications [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]Secondary outcome measures that will be studied are as follows: The changes in the number of cigarettes consumed per day or 'stage of change' at 4, 12, 24 and 52 weeks after the initial assigned target quit date. The incidence of perioperative complications (until 30 days after surgery) as well as medication-related adverse events (and serious adverse events) will also be recorded (only those who in the smoking-cessation program).
| Estimated Enrollment: | 296 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Smoking cessation group
Counselling, Pharmacotherapy and Smokers Help Line
|
Drug: Smoking cessation counselling group
The smoking-cessation program has three components; structured preoperative counseling, pharmacotherapy with varenicline for three months, and referral to the quit line (Smokers' Helpline) for proactive telephone counseling and follow up
|
|
Control group
Brief informatin about quitting and smokers help line
|
Other: Control group:
Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who smoke more than 10 cigarettes per day for more than 1 year
- And had no period of smoking abstinence longer than 3 months in the past year.
- Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients > 18 years of age
Exclusion Criteria:
- Patients unwilling or unable to give informed consent
- Patients who are pregnant and breast feeding
- Patients with any psychiatric disorder
- Patients who used nicotine replacement / bupropion within previous 3 months
- Cardiovascular disease within the past 6 months
- Any serious or unstable disease within the past 6 months
- Drug or alcohol abuse within the past year.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320462
Contacts
| Contact: Sazzadul Islam, M.Sc | pager 4167194736 | sazzadul.islam@uhn.on.ca |
| Contact: Uzma Nisar, MBBS | pager 4167194691 | unisar@uhnres.utoronto.ca |
Locations
| Canada, Ontario | |
| Toronto Western Hospital, Department of Aneshtesia | Recruiting |
| Toronto, Ontario, Canada, M5T2S8 | |
| Contact: Sazzadul Islam, M.Sc. 4166035800 ext 2508 sazzadul.islam@uhn.on.ca | |
| Principal Investigator: Frances Chung, FRCPC | |
| Sub-Investigator: jean Wong, MD | |
| Mount Sinai Hospital, Department of Anesthesia | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Uzma Nisar, MBBS pager 416 4194691 unisar@uhnres.utoronto.ca | |
| Principal Investigator: Frances Chung, FRCPC | |
| Sub-Investigator: Naveed Siddiqui, MD | |
| Sub-Investigator: Eric You-ten, MD | |
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
Investigators
| Principal Investigator: | Frances Chung, FRCPC | University Health Network, Toronto |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01320462 History of Changes |
| Other Study ID Numbers: | WS836526 |
| Study First Received: | March 21, 2011 |
| Last Updated: | June 13, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Smoking quit surgery anesthesia champix |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on June 17, 2013