Neuropsychological Prognosis Factors of Smoking Cessation

Phase 4

Completed

• Conditions: Nicotine Dependence; Smoking Cessation
• Interventions: Behavioral: neuropsychological assessment

• Registration Number: NCT01554436
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2011-05
• Study Completion: 2011-11
• Study First Submitted: 2012-02-24
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-15
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients in smoking cessation	neuropsychological assessment	patients in smoking cessation

Primary Outcome Measures

Name	Time	Method
neuropsychological test	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.

Secondary Outcome Measures

Name	Time	Method
Interactions neuropsychological performance and clinical conditions in patients with psychiatric desease	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.
Interactions neuropsychological performance and clinical conditions in patients with hyperactivity disorders	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.

Trial Locations

Locations (1)

CHRU de Montpellier; 🇫🇷 Montpellier, France