Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2007 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00429208

First Posted: January 31, 2007

Last Update Posted: July 25, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Hadassah Medical Organization

Tracking Information

First Submitted Date ^ICMJE

January 30, 2007

First Posted Date ^ICMJE

January 31, 2007

Last Update Posted Date

July 25, 2007

Start Date ^ICMJE

February 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Neurocognitive functions

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

Official Title ^ICMJE

Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers: A Double-Blind, Within-Subjects, Placebo-Controlled Study

Brief Summary

This research project addresses the hypothesis that a neurocognitive profile characterized by impairment of response inhibition and sustained attention may be a risk factor for smoking initiation and nicotine dependence among young women. Nicotine has short- term, facilitating effects on attention and response inhibition. Therefore, individuals who are impaired on cognitive functions such as these and initiate cigarette smoking may be more likely to maintain the habit and develop nicotine dependence. The research protocol specifically tests whether administration of nicotine to non-abstinent, regular cigarette smokers improves cognitive function in those domains where the participants had previously been shown to manifest performance deficits

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic

Condition ^ICMJE

Nicotine Dependence
Smoking
Tobacco Use Disorder
Nicotine Use Disorder

Intervention ^ICMJE

Drug: Nicotine

Study Arms

Not Provided

Publications *

Yakir A, Rigbi A, Kanyas K, Pollak Y, Kahana G, Karni O, Eitan R, Kertzman S, Lerer B. Why do young women smoke? III. Attention and impulsivity as neurocognitive predisposing factors. Eur Neuropsychopharmacol. 2007 Apr;17(5):339-51. Epub 2006 Nov 30.

* 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

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Reported smoking cigarettes on a daily basis at the time of the original study and continue to smoke currently
Manifested poor performance on the MFFT (The neurocognitive test that yielded differences between smokers and non-smokers)
Competent and willing to give written informed consent

Exclusion Criteria:

Pregnancy, breast-feeding, non-use of contraception such that the possibility of pregnancy cannot be excluded
Intake of any medication that may potentially interact with nicotine.
Any current or past medical condition that represents a contra-indication to nicotine administration.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years to 30 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Israel

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00429208

Other Study ID Numbers ^ICMJE

yakir@hmo

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Avi Yakir, MD

Hadassah Medical Organization

PRS Account

Hadassah Medical Organization

Verification Date

January 2007

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

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