Back to results

Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

Primary Purpose

Nicotine Dependence, Smoking, Tobacco Use Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Nicotine

About this trial

This is an interventional diagnostic trial for Nicotine Dependence focused on measuring Nicotine Dependence, Smoking, Tobacco Use Disorder, Nicotine Use Disorder

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Hadassah Medical Organization

Outcomes

Primary Outcome Measures

Neurocognitive functions

Secondary Outcome Measures

Full Information

NCT ID

NCT00429208

First Posted

January 30, 2007

Last Updated

January 30, 2007

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00429208

Brief Title

Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

February 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence, Smoking, Tobacco Use Disorder, Nicotine Use Disorder

Keywords

Nicotine Dependence, Smoking, Tobacco Use Disorder, Nicotine Use Disorder

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nicotine

Primary Outcome Measure Information:

Title

Neurocognitive functions

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Avi Yakir, MD

Phone

00 972 2 6777184

yakir@hadassah.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Hadas Lemberg, PhD

Phone

00 972 2 6777572

lhadas@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avi Yakir, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arik Tzukert, DMD

Phone

00 972 2 6776095

arik@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Hadas Lemberg, PhD

Phone

00 972 2 6777572

lhadas@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Avi Yakir, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

17141485

Citation

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.

Results Reference

result

Learn more about this trial

Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

We'll reach out to this number within 24 hrs