SmokingNCT01320462
Smoking Cessation Program in the Preadmission Clinic
A study testing Smoking cessation counselling group in people with Smoking, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Smoking cessation counselling group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2010to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto Western Hospital, Department of Aneshtesia
Toronto, Ontario, M5T2S8
Mount Sinai Hospital, Department of Anesthesia
Toronto, Ontario
About this study
Official title: Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line
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.
- Conditions
- Smoking
- Being tested
- Smoking cessation counselling group, Control group:
- Keywords
- Smoking, quit, surgery, anesthesia, champix
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation counselling groupDrug
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:Other
Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation group | Experimental | Counselling, Pharmacotherapy and Smokers Help Line Receives: Drug: Smoking cessation counselling group |
| Control group | Other | Brief informatin about quitting and smokers help line Receives: Other: Control group: |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-surgery counseling for quit smoking
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)
Measured: 1 year after surgery
Secondary outcomes (1)
perioperative complications
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).
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dr. Frances Chung, University Health Network, Toronto
- Investigators
- Frances Chung, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320462
- Sponsor's protocol ID
- WS836526
- Status last verified
- Jun 2016
- First submitted
- 21 Mar 2011
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line
- ClinicalTrials.gov ID
- NCT01320462
- Acronym / sponsor ID
- WS836526
- Conditions
- Smoking
- Keywords
- Smoking, quit, surgery, anesthesia, champix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2010
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation group | Experimental | Drug: Smoking cessation counselling groupCounselling, Pharmacotherapy and Smokers Help Line |
| Control group | Other | Other: Control group:Brief informatin about quitting and smokers help line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation counselling groupThe 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 | Drug | Smoking cessation group |
| Control group:Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information. | Other | Control group |
Primary outcome
pre-surgery counseling for quit smoking
Time frame: 1 year after surgery
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)
1 secondary outcome
perioperative complications
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Chung, FRCPC principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation counselling group in people with Smoking, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pre-surgery counseling for quit smoking (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.