Transcranial Direct Current Stimulation - Tobacco Use Disorder
赞助:
Central Institute of Mental Health, Mannheim
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | October 2018 | ||
| 预计主要完成日期 | August 2020 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Reduced number of cigarettes smoked[ Time Frame: First assessment on Day 1, second on Day 8 ] Smoking habits will be assessed via interview at the beginning of the study and after a follow-up period of three days. Number of cigarettes smoked will be compared longitudinally and between groups. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Transcranial Direct Current Stimulation - Tobacco Use Disorder | ||
| 正式标题 ICMJE | Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving | ||
| 简要概况 | This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods. |
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| 详细说明 | Participating smokers are to receive anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex (rDLPFC) for 20 minutes on five consecutive days. Neuropsychological tests on inhibitory control and interviews on smoking habits and craving will be applied before and after the first stimulation as well as after the fifth stimulation. After a follow-up period of three days, smoking behaviour will be assessed in a telephone interview. Changes in inhibitory control and smoking behaviour will be compared between an active and a sham stimulation group.This way the effects of transcranial direct current stimulation on tobacco use disorder are to be clarified. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation. 盲法: Interventional 盲法描述:Participants will be blinded as to their assigned study arm. 主要目的: Treatment |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
60 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | August 2020 | ||
| 预计主要完成日期 | August 2020 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - tobacco use disorder - normal or correctable eyesight - sufficient ability to communicate with the investigators, to answer questions in oral and written form - fully informed consent - written informed consent Exclusion Criteria: - withdrawal of the declaration of consent - exclusion criteria for tDCS (metal implants in the head, acute eczema, known epilepsy) - severe internal, neurological or psychiatric comorbidity - pharmacotherapy with psychoactive substances within the last 14 days - axis-I disorder according to ICD-10 and DSM 5 (except tobacco use disorder) - positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine) - pregnancy | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：65 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | Germany | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Central Institute of Mental Health, Mannheim | ||
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| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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