Neuropsychological Prognosis Factors of Smoking Cessation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Hospital, Montpellier.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University Hospital, Clermont-Ferrand
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01554436
First received: February 24, 2012
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Nicotine Dependence
Behavioral: neuropsychological assessment
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • neuropsychological test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Interactions neuropsychological performance and clinical conditions in patients with psychiatric desease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 135
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients in smoking cessation
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


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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554436

Locations
France
CHRU de Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Guillaume Sébastien, MD CHRU de Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01554436     History of Changes
Other Study ID Numbers: 8269, 2008-A00645-50
Study First Received: February 24, 2012
Last Updated: March 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
Smoking
Neuropsychology
Abstinence
Prognosis
Nicotine Dependence, Cigarettes, with Other Nicotine-induced Disorders

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits

ClinicalTrials.gov processed this record on July 22, 2014