Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of Participants Willing to Complete 5 Days of tDCS or Sham
研究概览
简要总结
In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between the ages of 18 and 64
- •Smoked (on average) at least 5 cigarettes per day
- •Be motivated to quit smoking
排除标准
- •Unstable medical or psychiatric conditions
- •Any medical conditions with neurological sequelae
- •History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae
- •Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications).
- •Are pregnant or planning to become pregnant during the study
- •Current use of pacemaker, intracranial electrodes or implanted defibrillator
结局指标
主要结局
Number of Participants Willing to Complete 5 Days of tDCS or Sham
时间窗: 5 days
As a feasibility study, the primary endpoint will be to determine if smokers are willing to enroll into and complete a study evaluating tDCS. Number of smokers enrolled and number who complete the 5 day tDCS procedures will be assessed.
次要结局
- Change in Number of Cigarettes Smoked Per Day(4 weeks)