Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Unknown status

CT.gov ID

NCT00429208

Collaborator

(none)

Enrollment

Location

1.9

Duration (Months)

20.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Nicotine Dependence Smoking Tobacco Use Disorder Nicotine Use Disorder	Drug: Nicotine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Feb 1, 2007

Anticipated Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Neurocognitive functions []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.