Measuring Smoking Behaviors While Using Varenicline

Completed · Phase 4 · Has a placebo group

Conditions studied: Nicotine Dependence

In brief

This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

Key facts

Study ID

NCT00948155

Run by

University of Pennsylvania

People needed

48

Starts

2009-01-01

Expected to finish

2010-11-01

Last updated by the study team

2014-12-16

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• self report minimum 10 daily cigarettes
• self report smoking every day past 5 years
• between the ages 21-65
• self report intention to try to quit smoking in the next 6 months

You may not qualify if…

• self reported use of any nicotine-containing products other than non-menthol cigarettes
• self reported history or current treatment of substance abuse (other than nicotine dependence)
• self reported alcohol use greater than 25 standard drinks per week;
• currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
• self reported history or current diagnosis of any Axis 1 disorders except past depression
• self reported serious or unstable disease within past year
• self reported history of epilepsy or seizure disorder;
• self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
• self reported kidney function impairment
• any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
• less than 5 years of daily smoking
• any medical condition or concomitant medication that could compromise participant safety or treatment
• provide a baseline carbon monoxide (CO) reading < 10 ppm
• self reported use of non filtered cigarettes
• inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician

Where it is running

• Tobacco Use Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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