Varenicline and Nicotine Interactions in Humans (VA)
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 Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Varenicline in Nicotine Interactions in Humans (VA)|
- Will help stop smoking cessations. [ Time Frame: 4 to 14 days per subject ] [ Designated as safety issue: No ]
- Looking to see if the study medication improves subjects ability to perform tasks while given nicotine. [ Time Frame: 4 to 14 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Varenicline given 70kg/day
Placebo Comparator: 2
placebo: sugar pill
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606892
|United States, Connecticut|
|Veterans Affairs Hospital|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D., Ph.D.||Yale University Associate Professor|