Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

Tracking Information
First Submitted Date ICMJE	January 30, 2007
First Posted Date ICMJE	January 31, 2007
Last Update Posted Date	January 31, 2007
Study Start Date ICMJE	February 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: January 30, 2007)	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 Applicable
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; (submitted: January 30, 2007)	40
Original Enrollment ICMJE	Same as current
Estimated Study 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