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Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00429208
First received: January 30, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Smoking
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Biological Psychiatry Laboratory Hadassah- Hebrew University Medical Center, Jerusalem, Israel  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00429208     History of Changes
Other Study ID Numbers: yakir@hmo
Study First Received: January 30, 2007
Last Updated: January 30, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013