Neuropsychological Prognosis Factors of Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554436
• Other study ID #: 8269
• Secondary ID: 2008-A00645-50
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2012
• Last updated: December 30, 2014
• Start date: December 2008
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• neuropsychological assessment
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

Locations

Country	Name	City	State
France	CHRU de Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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.	6 months	No
Secondary	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.	6 months	No