Varenicline and Nicotine Interactions in Humans (VA)

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Nicotine; Varenicline

Criteria

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

• Carbon Monoxide (Alveolar) 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