NCT00429208

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

January 31, 2007

Status Verified

January 1, 2007

First QC Date

January 30, 2007

Last Update Submit

January 30, 2007

Conditions

Keywords

Nicotine DependenceSmokingTobacco Use DisorderNicotine Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive functions

Interventions

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related 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. doi: 10.1016/j.euroneuro.2006.09.004. Epub 2006 Nov 30.

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Avi Yakir, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2007

First Posted

January 31, 2007

Study Start

February 1, 2007

Study Completion

April 1, 2007

Last Updated

January 31, 2007

Record last verified: 2007-01

Locations