Clinical trial NCT01554436: Neuropsychological Prognosis Factors of Smoking Cessation
Official title: Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Nicotine Dependence
Keywords: Smoking
Neuropsychology
Abstinence
Prognosis
Nicotine Dependence, Cigarettes, with Other Nicotine-induced Disorders
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
First posted: 2012-03-15
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: neuropsychological test
timeFrame: 6 months
Secondary outcomes:
measure: Interactions neuropsychological performance and clinical conditions in patients with psychiatric desease
timeFrame: 6 months
measure: Interactions neuropsychological performance and clinical conditions in patients with hyperactivity disorders
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier
Study officials:
affiliation: CHRU de Montpellier
name: Guillaume Sébastien, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.