Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00429208
• Other study ID #: yakir@hmo
• Status: Not yet recruiting
• Phase: N/A
• First received: January 30, 2007
• Last updated: January 30, 2007
• Start date: February 2007
• Est. completion date: April 2007

Study information

• Verified date: January 2007
• Source: Hadassah Medical Organization
• Contact: Avi Yakir, MD
• Phone: 00 972 2 6777184
• Email: yakir[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Disease
• Nicotine Dependence
• Nicotine Use Disorder
• Smoking
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive functions

External Links

•   Biological Psychiatry Laboratory Hadassah- Hebrew University Medical Center, Jerusalem, Israel