Neuropsychological Prognosis Factors of Smoking Cessation
| Tracking Information | |||||
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| First Received Date ICMJE | February 24, 2012 | ||||
| Last Updated Date | March 12, 2012 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01554436 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neuropsychological Prognosis Factors of Smoking Cessation | ||||
| Official Title ICMJE | Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: patients in smoking cessation
patients in smoking cessation
Intervention: Behavioral: neuropsychological assessment |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 135 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01554436 | ||||
| Other Study ID Numbers ICMJE | 8269, 2008-A00645-50 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital, Montpellier | ||||
| Study Sponsor ICMJE | University Hospital, Montpellier | ||||
| Collaborators ICMJE | University Hospital, Clermont-Ferrand | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Montpellier | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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