Neuropsychological Prognosis Factors of Smoking Cessation

NCT ID: NCT01554436

Last Updated: 2014-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-11-30

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.

Conditions

Smoking Cessation; Nicotine Dependence

Keywords

Smoking; Neuropsychology; Abstinence; Prognosis; Nicotine Dependence, Cigarettes, with Other Nicotine-induced Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients in smoking cessation

patients in smoking cessation

Group Type: EXPERIMENTAL

neuropsychological assessment

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Sébastien, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Montpellier

Locations

CHRU de Montpellier

Montpellier, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 26953688 (View on PubMed)

Other Identifiers

2008-A00645-50

Identifier Type: OTHER

Identifier Source: secondary_id

8269

Identifier Type: -

Identifier Source: org_study_id