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临床试验/NCT03691805
NCT03691805已完成不适用

Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving

Central Institute of Mental Health, Mannheim1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Reduced number of cigarettes smoked

研究概览

简要总结

This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be blinded as to their assigned study arm.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Reduced number of cigarettes smoked

时间窗: 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.

次要结局

  • Reduced Carving(First assessment on Day 1, second on Day 5, third on Day 8)
  • Increased inhibitory control(First and second testing on Day 1, third testing on Day 5)

研究者

发起方
Central Institute of Mental Health, Mannheim
申办方类型
Other
责任方
Sponsor

研究点 (1)

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