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Neuropsychological Prognosis Factors of Smoking Cessation

Primary Purpose

Smoking Cessation, Nicotine Dependence

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
neuropsychological assessment
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Smoking Cessation focused on measuring Smoking, Neuropsychology, Abstinence, Prognosis, Nicotine Dependence, Cigarettes, with Other Nicotine-induced Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 18-60 years old
  • Patient applying for withdrawal regardless of the number of P / A, the length of smoking.
  • Patient with nicotine dependence (Fagerstrom Test score > or = 3)
  • Patient able to understand the nature, purpose and methodology of the study
  • Patient who gave written informed consent to participate in the study
  • Patient agree to cooperate in the clinical and neuropsychological evaluation
  • Patient affiliated to a French social security system

Exclusion Criteria:

  • Patient with a physical disease being able to interact with the cognitive performances: dysthyroidies, pituitary adenomas, neurodegenerative diseases, Parkinson's disease, neoplastic diseases with intellectual location, the central neurological disorders, the cranial traumas.
  • Patient in the incapacity to answer at neuropsychological tests
  • Patient who can't go back at visits in 6 months
  • Pregnancy women

Sites / Locations

  • CHRU de Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients in smoking cessation

Arm Description

patients in smoking cessation

Outcomes

Primary Outcome Measures

neuropsychological test
There primary outcome is to assess if smokers with low attentional level (defined has the median of the sample in Nback and RVIP tasks) are at higher level of relapse at 6 months.

Secondary Outcome Measures

Interactions neuropsychological performance and clinical conditions in patients with psychiatric desease
To study other cognitive performance such as decision making abilities on smoking cessation rates at 6 months. To assess in transversal design the link beetween cognitive functioning and some well known pronostic factors of smoking cessation such as motivation or craving before smoking initiation To study the interaction between neuropsychological performance and clinical conditions that may affect cognitive performance on the rate of abstinence. These tests will be done in subgroups of patients with the characteristic of interest such as a current depressive disorders.
Interactions neuropsychological performance and clinical conditions in patients with hyperactivity disorders
To study other cognitive performance such as decision making abilities on smoking cessation rates at 6 months. To assess in transversal design the link beetween cognitive functioning and some well known pronostic factors of smoking cessation such as motivation or craving before smoking initiation To study the interaction between neuropsychological performance and clinical conditions that may affect cognitive performance on the rate of abstinence. These tests will be done in subgroups of patients with the characteristic of interest such as a current hyperactivity disorders.

Full Information

First Posted
February 24, 2012
Last Updated
December 30, 2014
Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT01554436
Brief Title
Neuropsychological Prognosis Factors of Smoking Cessation
Official Title
Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Clermont-Ferrand

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The low overall effectiveness of available smoking cessation treatment so far, indicate the need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a highly heterogeneous population. Identification of individual characteristics that predict success in smoking cessation is highly desirable to allow designing more specific strategies in order to enhance success in quitting tobacco.The main objective of this study is to assess whether the presence of certain neuropsychological deficits found before the initiation of smoking cessation is associated with a greater relapse rate.The secondary objectives concern how neuropsychological performance are involved in motivation and craving in the whole sample of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological factors associated with agood or poor prognosis for success and provived more specific and therefore more effective care.
Detailed Description
This is a prospective multicenter study. Patients will be recruited to anti tobacco consultations in the Montpellier and Clermont-Ferrand University Hospitals. The initial assessment includes a clinical assessment of smoking history, Axis I disorders history, motivation to quit and craving, a neuropsychological assessment : NART, RVIP task, trail Making Test, Stroop, Iowa gambling task, Hayling test, N back, verbal fluency. Then patients will be reviewed 3 times in 6 months. These visits include: CO level and cigarette consumption since the last visit, cessation strategy (medication, observance … ), tobacco craving questionnary, withdrawal symptoms, abstinence. The primary endpoint will be smoking abstinence objectified by the rate of carbon monoxide measured at each visit. Subjects who emerge from the study prematurely, especially patients lost to follow will be considered as failures in the statistical analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Nicotine Dependence
Keywords
Smoking, Neuropsychology, Abstinence, Prognosis, Nicotine Dependence, Cigarettes, with Other Nicotine-induced Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients in smoking cessation
Arm Type
Experimental
Arm Description
patients in smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
neuropsychological assessment
Intervention Description
The main criterion of evaluation of the smoking abstinence will be made by the measure of the rate of carbon monoxide (CO) in the expired air between the study start and during the study until 6 months after inclusion. The secondary criteria of evaluation are criteria of neuropsychological order, namely the performances in the tests listed: result of NART test,Continuous Performance Test (CPT), Trail Making test, Stroop test, Iowa gambling task. (IGT), Hayling test, N back test, fluence verbal test
Primary Outcome Measure Information:
Title
neuropsychological test
Description
There primary outcome is to assess if smokers with low attentional level (defined has the median of the sample in Nback and RVIP tasks) are at higher level of relapse at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Interactions neuropsychological performance and clinical conditions in patients with psychiatric desease
Description
To study other cognitive performance such as decision making abilities on smoking cessation rates at 6 months. To assess in transversal design the link beetween cognitive functioning and some well known pronostic factors of smoking cessation such as motivation or craving before smoking initiation To study the interaction between neuropsychological performance and clinical conditions that may affect cognitive performance on the rate of abstinence. These tests will be done in subgroups of patients with the characteristic of interest such as a current depressive disorders.
Time Frame
6 months
Title
Interactions neuropsychological performance and clinical conditions in patients with hyperactivity disorders
Description
To study other cognitive performance such as decision making abilities on smoking cessation rates at 6 months. To assess in transversal design the link beetween cognitive functioning and some well known pronostic factors of smoking cessation such as motivation or craving before smoking initiation To study the interaction between neuropsychological performance and clinical conditions that may affect cognitive performance on the rate of abstinence. These tests will be done in subgroups of patients with the characteristic of interest such as a current hyperactivity disorders.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 18-60 years old Patient applying for withdrawal regardless of the number of P / A, the length of smoking. Patient with nicotine dependence (Fagerstrom Test score > or = 3) Patient able to understand the nature, purpose and methodology of the study Patient who gave written informed consent to participate in the study Patient agree to cooperate in the clinical and neuropsychological evaluation Patient affiliated to a French social security system Exclusion Criteria: Patient with a physical disease being able to interact with the cognitive performances: dysthyroidies, pituitary adenomas, neurodegenerative diseases, Parkinson's disease, neoplastic diseases with intellectual location, the central neurological disorders, the cranial traumas. Patient in the incapacity to answer at neuropsychological tests Patient who can't go back at visits in 6 months Pregnancy women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Sébastien, MD
Organizational Affiliation
CHRU de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26953688
Citation
Flaudias V, Picot MC, Lopez-Castroman J, Llorca PM, Schmitt A, Perriot J, Georgescu V, Courtet P, Quantin X, Guillaume S. Executive Functions in Tobacco Dependence: Importance of Inhibitory Capacities. PLoS One. 2016 Mar 8;11(3):e0150940. doi: 10.1371/journal.pone.0150940. eCollection 2016.
Results Reference
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Neuropsychological Prognosis Factors of Smoking Cessation

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