Tobacco Dependence Clinical Trial
Official title:
Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement
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.
Status | Completed |
Enrollment | 163 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Country | Name | City | State |
---|---|---|---|
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tonic Craving Score (QSU) Based on Self Reports | Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues. | 3 weeks per participant | No |
Primary | Cue-provoked Cravings | Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale "How strong was your craving to smoke a cigarette?" | 3 weeks per participant | No |
Secondary | Smoking Topography - Number of Puffs on a Cigarette | # Puffs = total number of puffs taken at Assessment Session. | 3 weeks per participant | No |
Secondary | A Measure of the Subjective Expected Value of a Cigarette | The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007). | 3 weeks per participant | No |
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