Expired Study
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Tampa, Florida 33612


Purpose:

The purpose of this study is 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 is trying to evaluate whether varenicline will change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This is not a quit smoking treatment study, and participants will not be asked or required to stop smoking while in this study.


Study summary:

We propose the following primary hypotheses: 1. Tonic (i.e., non-cue-provoked) craving levels will be lower in participants receiving varenicline versus placebo. 2. Cue-provoked cravings (self-report and physiological responding) will be lower in participants receiving varenicline versus placebo. (Secondary indices of craving include heart rate and skin conductance.) 3. The two primary indices of nicotine reward/reinforcement (mCEQ and choice index) will be lower in participants receiving varenicline versus placebo. (Secondary indices of nicotine reinforcement include smoking topography variables.) One hundred twenty six (126) non-treatment seeking daily smokers will be 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 will be randomly assigned to receive either varenicline or placebo medication.


Criteria:

Inclusion Criteria: - 18-60 years of age - Smoke at least 15 cigarettes daily - Expired-air carbon monoxide (CO) > 10 ppm - Medically eligible to receive Varenicline. Exclusion Criteria: - 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


NCT ID:

NCT00747643


Primary Contact:

Principal Investigator
Thomas Brandon, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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