An Alternative Dosing Schedule of Varenicline for Smoking Cessation
NCT00835900
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Adult Trials: 18+ Years
- currently smoking at least 15 cigarettes daily
- in good health
- able to read and speak English fluently
- have a home telephone and plan to reside in Western New York for 6 months
- willing to make quit attempt
- signed informed consent
- who planned quit attempt.
- serious medical condition
- depression or mental health condition requiring treatment in the past year
- history of panic disorder, psychosis, bipolar disorder
- alcohol or drug abuse in the past year
- use of tobacco products other than cigarettes
- current use of other cessation pharmacotherapies
- pregnancy/planned pregnancy.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | An Alternative Dosing Schedule of Varenicline for Smoking Cessation | |||
| Official Title ICMJE | Extended Varenicline for Smoking Cessation: A Pilot Study | |||
| Brief Summary | The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence. | |||
| Detailed Description | This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Smoking Cessation | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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 | 60 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | July 2015 | |||
| Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00835900 | |||
| Other Study ID Numbers ICMJE | I 136208 Pfizer IIR-GA30523 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Roswell Park Cancer Institute | |||
| Study Sponsor ICMJE | Roswell Park Cancer Institute | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
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| PRS Account | Roswell Park Cancer Institute | |||
| Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||