Status:
COMPLETED
Varenicline and Nicotine Interactions in Humans (VA)
Lead Sponsor:
Yale University
Collaborating Sponsors:
US Department of Veterans Affairs
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00606892
Start Date
August 1 2007
End Date
November 1 2009
Last Update
September 25 2014
Active Locations (1)
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1
Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516