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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: January 31, 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
  Purpose
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 Intervention
Nicotine Dependence Smoking Tobacco Use Disorder Nicotine Use Disorder Drug: Nicotine

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Neurocognitive functions

Estimated Enrollment: 40
Study Start Date: February 2007
Estimated Study Completion Date: April 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429208


Contacts
Contact: Avi Yakir, MD 00 972 2 6777184 yakir@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Avi Yakir, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Avi Yakir, MD Hadassah Medical Organization
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00429208     History of Changes
Other Study ID Numbers: yakir@hmo
First Submitted: January 30, 2007
First Posted: January 31, 2007
Last Update Posted: January 31, 2007
Last Verified: January 2007

Keywords provided by Hadassah Medical Organization:
Nicotine Dependence
Smoking
Tobacco Use Disorder
Nicotine Use Disorder

Additional relevant MeSH terms:
Disease
Tobacco Use Disorder
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action