Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

January 30, 2007 updated by: Hadassah Medical Organization

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Neurocognitive functions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Avi Yakir, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (Anticipated)

April 1, 2007

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 30, 2007

First Posted (Estimate)

January 31, 2007

Study Record Updates

Last Update Posted (Estimate)

January 31, 2007

Last Update Submitted That Met QC Criteria

January 30, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yakir@hmo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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