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Varenicline and Nicotine Interactions in Humans (VA)

This study has been completed.
Sponsor:
Collaborators:
Department of Veterans Affairs
National Institute on Drug Abuse (NIDA)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00606892
First received: January 23, 2008
Last updated: April 4, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Smoking Cessation
 Drug: varenicline
Drug: placebo

Study Type: Interventional
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Will help stop smoking cessations. [ Time Frame: 4 to 14 days per subject ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: August 2007
Study Completion Date: November 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Varenicline given 70kg/day
 Drug: varenicline
varenicline 70kg/day
Placebo Comparator: 2
placebo: sugar pill
 Drug: placebo
sugar pill

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 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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606892

Locations
United States, Connecticut
Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Department of Veterans Affairs
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University Associate Professor
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu M.D., Ph.D., Yale University
ClinicalTrials.gov Identifier: NCT00606892     History of Changes
Other Study ID Numbers: HIC # 0702002338, MIRECC 000000000, DPMC
Study First Received: January 23, 2008
Last Updated: April 4, 2011
Health Authority: United States: Federal Government

Keywords provided by Yale University:
therapeutic effects

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013