Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Smoking Cessation
研究概览
简要总结
The purpose of this study is to determine the effectiveness of transcranial direct current stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine dependent smokers.
详细描述
BACKGROUND: Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that involves the application of brief weak electric current to the scalp. tDCS may induce neuroplasticity, thereby engaging some of the same systems that figure prominently in the pathological neuroplasticity caused by addictive drugs.
OBJECTIVE
To assess whether tDCS delivered along with nicotine patch reliably increases a) quit rates, b) duration of abstinence, and c) percentage of participants abstinent at follow-up.
METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the dorsolateral prefrontal cortex (DLPFC) in both cerebral hemispheres.
HYPOTHESES:
- Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation protocol relative to a sham procedure.
- The benefits of active left anodal stimulation (anode-left/cathode-right) to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nicotine dependent
- •treatment-seeking
- •smoke minimum of 15 cigarettes per day
- •able to provide written informed consent
- •able and willing to attend weekly appointments, inter-treatment and follow-up assessment
- •able and willing to wear nicotine patch
排除标准
- •currently taking GABA receptor agonists, NMDA receptor antagonists, dopamine receptor agonists/antagonists, SSRIs, L-dopa, anticholinergics
- •pregnancy or lactation
- •any serious medical condition requiring treatment or medication including high blood pressure, heart problems, asthma, epilepsy
- •brain/neurological injury/disease/disorder
- •skin disease
- •current DSM-IV Axis I psychiatric disorder
- •metal or medical device implants
- •current treatment for alcohol or drug use
- •current use of herbal/holistic preparations
- •current use of recreational drugs
结局指标
主要结局
Smoking Cessation
时间窗: Participants will be followed for the duration of the study, an expected average of 9 months.
Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure
次要结局
未报告次要终点
研究者
Laurie Zawertailo
Principal Investigator
Centre for Addiction and Mental Health