Varenicline and Nicotine Interactions in Humans (VA) - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00606892

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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment
Official Title:	Varenicline in Nicotine Interactions in Humans (VA)

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 give nicotine. [ Time Frame: 4 to 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	August 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Varenicline given 70kg/day	Drug: varenicline varenicline 70kg/day
2: Placebo Comparator 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 is still active. Recruitment is still ongoing with human subjects. Currently we have 12 completers.

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

Contacts

Contact: Lance Barnes

203-937-4823

lance.barnes@yale.edu

Locations

United States, Connecticut
Veterans Affairs Hospital	Recruiting
West Haven, Connecticut, United States, 06516
Contact: Mehmet Sofuoglu, M.D., Ph.D. 203-937-4809 mehmet.sofuoglu@yale.edu
Contact: Kishorchandra Gonsai, M.D. 203-932-5711 ext 4371 kishorchandra.gonsai@va.gov

Sponsors and Collaborators

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:	Yale University, Associate Professor ( Mehmet Sofuoglu M.D., Ph.D. )
Study ID Numbers:	HIC # 0702002338, MIRECC 000000000, 5 K02 DA021304-02
Study First Received:	January 23, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00606892 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

therapeutic effects

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine
Varenicline

ClinicalTrials.gov processed this record on September 03, 2009