Neuropsychological Prognosis Factors of Smoking Cessation

Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Nicotine Dependence
• Intervention / Treatment: Behavioral: neuropsychological assessment

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: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: patients in smoking cessation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Guillaume Sébastien, MD, CHRU de Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Prognosis; Smoking; Neuropsychology; Abstinence; Nicotine Dependence, Cigarettes, with Other Nicotine-induced Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 8269 (CTEP); 2008-A00645-50 (Other Identifier: ID-RCB)