Neuropsychological and Psychopathological Prognosis Factors of Smoking Cessation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- neuropsychological test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
neuropsychological test
时间窗: 6 months
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.
次要结局
- Interactions neuropsychological performance and clinical conditions in patients with psychiatric desease(6 months)
- Interactions neuropsychological performance and clinical conditions in patients with hyperactivity disorders(6 months)