Varenicline and Nicotine Interactions in Humans (VA)

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00606892
First received: January 23, 2008
Last updated: April 4, 2011
Last verified: April 2011

January 23, 2008
April 4, 2011
August 2007
November 2008   (final data collection date for primary outcome measure)
Will help stop smoking cessations. [ Time Frame: 4 to 14 days per subject ] [ Designated as safety issue: No ]
Treatment will attenuate the subjective, physiological and cognitive responses to IV nicotine. [ Time Frame: 4 to 14 days per subject ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00606892 on ClinicalTrials.gov Archive Site
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 ]
Varenicline will intensify subjects cognition with IV nicotine [ Time Frame: 4 to 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Varenicline and Nicotine Interactions in Humans (VA)
Varenicline in 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.

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)

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Smoking Cessation
  • Drug: varenicline
    varenicline 70kg/day
  • Drug: placebo
    sugar pill
  • Active Comparator: 1
    Varenicline given 70kg/day
    Intervention: Drug: varenicline
  • Placebo Comparator: 2
    placebo: sugar pill
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2009
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606892
HIC # 0702002338, MIRECC 000000000, DPMC
Yes
Mehmet Sofuoglu M.D., Ph.D., Yale University
Yale University
  • Department of Veterans Affairs
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University Associate Professor
Yale University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP