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Neuropsychological Prognosis Factors of Smoking Cessation

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status and phase

Completed
Phase 4

Conditions

Nicotine Dependence
Smoking Cessation

Treatments

Behavioral: neuropsychological assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT01554436
2008-A00645-50 (Other Identifier)
8269

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

135 participants in 1 patient group

patients in smoking cessation
Experimental group
Description:
patients in smoking cessation
Treatment:
Behavioral: neuropsychological assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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