Smoking Cessation Program in the Preadmission Clinic: The Use of a Teachable Moment
NCT01243203
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- The investigators will recruit patients who are assessed in preadmission clinic and scheduled for elective surgical procedures within the next 8 to 30 days.
- Patients should be 18 yrs of age, 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.
- current pregnancy, 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;
- and 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 will
be excluded.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Smoking Cessation Program in the Preadmission Clinic: The Use of a Teachable Moment | ||
| Official Title ICMJE | Not Provided | ||
| Brief Summary | 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. The investigators 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. A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Not Applicable | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Supportive Care | ||
| Condition ICMJE | Smoking | ||
| Intervention ICMJE | Drug: Champix
Days 1 - 3: 0.5 mg once daily (1 table each day) Days 4 - 7: 0.5 mg twice daily (1 in the morning and 1 in the evening) Days 8 - 12 weeks 1.0 mg twice daily (1 in the morning and 1 in the evening) | ||
| Study Arms ICMJE | Placebo Comparator: Placebo
patient will receive placebo pills Intervention: Drug: Champix | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Actual Enrollment ICMJE | 300 | ||
| Original Actual Enrollment ICMJE | Same as current | ||
| Actual Study Completion Date ICMJE | November 2011 | ||
| Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Canada | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01243203 | ||
| Other Study ID Numbers ICMJE | GA30517W | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Dr. Frances Chung, University Health Network, Toronto | ||
| Study Sponsor ICMJE | University Health Network, Toronto | ||
| Collaborators ICMJE | Pfizer | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | University Health Network, Toronto | ||
| Verification Date | November 2013 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||