Expired Study
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West Haven, Connecticut 06516


To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. Varenicline is expected to ease responses to IV nicotine. Varenicline treatment will ease the subjective, physiological and cognitive responses to IV nicotine.

Study summary:

This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine. This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment. This study has been completed. Currently this study is published. (April 2011)


Inclusion Criteria: - Female and male smokers, aged 18 to 55 years - History of smoking daily for the past 12 months, at least 15 cigarettes daily - CO level > 10ppm - For women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods Exclusion Criteria: - History of heart disease, renal or hepatic diseases - other medical conditions that the physician investigator deems as contraindicated for the subject to be in the study - Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) - recent psychiatric diagnosis and treatment for Axis I disorders including - major depression, bipolar affective disorder, - schizophrenia and panic disorder within the past year - Current dependence on alcohol - drugs or treatments for drug - alcohol addiction within the past 5 years - Allergy to varenicline



Primary Contact:

Principal Investigator
Mehmet Sofuoglu, M.D., Ph.D.
Yale University Associate Professor

Backup Contact:


Location Contact:

West Haven, Connecticut 06516
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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