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

Tracking Information

First Received Date ^ICMJE

January 23, 2008

Last Updated Date

April 4, 2011

Start Date ^ICMJE

August 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00606892 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Varenicline will intensify subjects cognition with IV nicotine [ Time Frame: 4 to 14 days ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Varenicline and Nicotine Interactions in Humans (VA)

Official Title ^ICMJE

Varenicline in Nicotine Interactions in Humans (VA)

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 smoking cessation. Varenicline is expected to ease responses to IV nicotine.

Varenicline treatment will ease the subjective, physiological and cognitive responses to IV nicotine.

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)

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Smoking Cessation

Intervention ^ICMJE

Drug: varenicline
varenicline 70kg/day
Drug: placebo
sugar pill

Study Arm (s)

Active Comparator: 1
Varenicline given 70kg/day

Intervention: Drug: varenicline
Placebo Comparator: 2
placebo: sugar pill

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00606892

Other Study ID Numbers ^ICMJE

HIC # 0702002338, MIRECC 000000000, DPMC

Has Data Monitoring Committee

Yes

Responsible Party

Mehmet Sofuoglu M.D., Ph.D., Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Department of Veterans Affairs
National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Mehmet Sofuoglu, M.D., Ph.D.

Yale University Associate Professor

Information Provided By

Yale University

Verification Date

April 2011

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

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