Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
NCT00747643
ABOUT THIS STUDY
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- 18-60 years of age
- Smoke at least 15 cigarettes daily
- Expired-air carbon monoxide (CO) > 10 ppm
- Medically eligible to receive Varenicline.
- Patients who are pregnant or lactating
- Who show evidence of renal dysfunction (BUN > 25 mg/dL, or creatinine > 1.3 mg/dL)
- Are using other smoking cessation medications
- Have current psychiatric disorders (i.e. major depression, manic depression, and/or
psychotic episodes) as determined by the Structured Clinical Interview for DSM
Disorders (SCID) (First et al., 1996), will be excluded
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Descriptive Information | ||||
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Brief Title ICMJE | Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement | |||
Official Title ICMJE | Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement | |||
Brief Summary | The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix?, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study. | |||
Detailed Description | We proposed the following primary hypotheses:
A final sample of 100 non-treatment seeking daily smokers were recruited from the Tampa-St. Petersburg-Clearwater Metropolitan Area via paid advertisements in, and press releases to, local newspapers, as well as targeted outdoor advertising via flyers (e.g., on public transportation). Following the screening session, participants were randomly assigned to receive either varenicline or placebo medication. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) | |||
Condition ICMJE | Tobacco Dependence | |||
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 | 163 | |||
Original Estimated Enrollment ICMJE | 126 | |||
Actual Study Completion Date ICMJE | August 2010 | |||
Actual Primary Completion Date | August 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 60 Years (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 | NCT00747643 | |||
Other Study ID Numbers ICMJE | MCC-15444 106842 ( Other Identifier: USF IRB ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | |||
Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | H. Lee Moffitt Cancer Center and Research Institute | |||
Verification Date | October 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |