Neuropsychological Prognosis Factors of Smoking Cessation
Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34295
- CHRU de Montpellier
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patients in smoking cessation
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neuropsychological test
Time Frame: 6 months
|
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.
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interactions neuropsychological performance and clinical conditions in patients with psychiatric desease
Time Frame: 6 months
|
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.
|
6 months
|
|
Interactions neuropsychological performance and clinical conditions in patients with hyperactivity disorders
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guillaume Sébastien, MD, CHRU de Montpellier
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8269 (CTEP)
- 2008-A00645-50 (Other Identifier: ID-RCB)
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