Transcranial Magnetic Stimulation Effects on Nicotine Craving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- the Change From Baseline in Cue Nicotine Craving Rating Score
研究概览
简要总结
The proposed study will measure the change of cortical excitability during nicotine craving and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine craving and cue-reactivity among adult regular smokers.
详细描述
This pilot protocol proposes to test and further develop TMS for the purpose of studying brain function in nicotine users.
Specific Primary Aims include:
Aim # 1. To test change of cortical excitability during nicotine craving in cigarette smokers and explore the potential use of TMS in cigarette smokers.
Aim # 2. Given the role of the prefrontal cortex (and connected regions) in craving, we will examine whether modulating prefrontal activity through rTMS will impact measures of craving and the reinforcing effects of nicotine.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right handed males and females, between the ages of 18 and 50
- •Daily smokers who smoke at least 10 cigarettes per day for at least past 1 year
- •Mentally capable of reading, writing, giving consent, following instructions
排除标准
- •history of seizures
- •taking medications that lower seizure threshold
- •implanted metal devices (e.g., pacemakers, metal plates, wires)
- •history of brain surgery or history of loss of consciousness >15 minutes
- •any unstable major axis I psychiatric disorder in the past month (e.g. psychotic disorders)
- •Current substance use disorders other than nicotine and caffeine use, in the past 30 days
- •Any medication (e.g., propranolol) or unstable medical condition that may interfere with psychophysiological (e.g., heart rate) monitoring
结局指标
主要结局
the Change From Baseline in Cue Nicotine Craving Rating Score
时间窗: Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)
Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.
次要结局
- the Change From Baseline in Resting Motor Threshold(20 minutes before (baseline) and 20 minutes after rTMS experiment)