Varenicline Observational Investigation In The Cessation of Smoking
NCT00669240
Last updated date
ABOUT THIS STUDY
The purpose of this study is to determine the safety and efficacy of varenicline in the
real-world environment of smokers attending primary care in routine clinical practice with
the addition of being offered behavioral support "Life REWARDS"TM. This is a
non-interventional study.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes.
- The patients must be willing to make an attempt to stop smoking.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- All patients enrolled should meet the usual prescribing criteria for varenicline as
per SmPC and should be entered into the trial at the Investigators discretion.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Varenicline Observational Investigation In The Cessation of Smoking | |||
| Official Title | Champix Observational Investigation In The Cessation of Smoking | |||
| Brief Summary | The purpose of this study is to determine the safety and efficacy of varenicline in the real-world environment of smokers attending primary care in routine clinical practice with the addition of being offered behavioral support "Life REWARDS"TM. This is a non-interventional study. | |||
| Detailed Description | Sampling Method Details: Patients as they come to surgeries for smoking cessation treatment. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes. The patients must be willing to make an attempt to stop smoking. All patients enrolled should meet the usual prescribing criteria for varenicline as per SmPC and should be entered into the trial at the Investigators discretion. | |||
| Condition | Smoking Cessation | |||
| Intervention | Drug: Varenicline
According to the approved Summary of Product Characteristics (SmPC), patients will be required to orally take 0.5 mg once daily for the first 3 days and titrate up to 0.5 mg twice daily for days 4 - 7. From day 8 to the end of treatment patients should take 1 mg twice daily. Patients who cannot tolerate adverse effects of Champix may have the dose lowered temporarily or permanently to 0.5 mg twice daily. Patients should be treated for 12 weeks. Treatment should start 1 - 2 weeks prior to quitting smoking. Other Name: Champix, Chantix, CP-526,555 | |||
| Study Groups/Cohorts | 1. Non-interventional
Patients prescribed varenicline in a non interventional manner. Intervention: Drug: Varenicline | |||
| Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 567 | |||
| Original Estimated Enrollment | 1000 | |||
| Actual Study Completion Date | August 2009 | |||
| Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Belgium, Greece, Hungary, Slovenia | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00669240 | |||
| Other Study ID Numbers | A3051085 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2015 | |||