Transcranial Direct Current Stimulation (TDCS) and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Cigarettes per Smoking Day
研究概览
简要总结
The purpose of the phase 1 translational pilot study proposed here is to gather preliminary data investigating the efficacy of transcranial direct current stimulation (TDCS) and cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The recent use of TDCS over task relevant regions to alter behavior holds incredible promise for use in cognitive retraining intervention protocols. Previous studies of cognitive retraining have focused on implicit training techniques. This proposed study will attempt to enhance these implicit training techniques through the use of TDCS during implicit retraining in order to increase learning of avoidance-related action tendencies towards tobacco. The objective of this pilot study is to establish the feasibility and obtain preliminary data on the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette smoking in individuals with nicotine addiction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consume 10 or more cigarettes/day average for the past 60 days
- •Able to provide informed consent
- •Less than 3 months smoking abstinence in the past year
- •Right Handed
排除标准
- •Serious medical illness within 6 months (e.g. cancer, hepatic, or renal disease)
- •Significant cardiovascular disease (e.g. recent stroke or heart attack, arrhythmias, worsening angina pectoris, uncontrolled hypertension) generalized skin disorders, or sensitivity to the nicotine patch
- •Use of illicit drugs (excluding marijuana) in the previous 30 days
- •Psychosis, psychotic disorder, or bipolar disorder
- •Current active major depression (depressive episode within last month)
- •Clinically significant suicidal ideation
- •Prior seizure
- •Current bupropion or tricyclic antidepressants
- •Current pregnancy, trying to become pregnant, or breastfeeding
- •Current active alcohol dependence (symptoms in last 30 days)
- •Left-handedness
- •Current medication known to interact with nicotine replacement therapy (NRT) or smoking cessation (e.g. adenosine, cimetidine, conivaptan, cyproterone, peginterferon alfa-2bg, tocilizumab, theophylline)
- •Metal in the head
- •Implanted brain medical devices
- •Electromedical devices
- •Latex Allergy
研究组 & 干预措施
Active TDCS + Active Retraining
2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
干预措施: Active Retraining (Behavioral)
Active TDCS + Active Retraining
2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
干预措施: Active transcranial direct current stimulation (TDCS) (Device)
Active TDCS + Active Retraining
2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
干预措施: Nicotine Replacement Therapy (Habitrol) (Drug)
Sham TDCS + Active Retraining
0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
干预措施: Active Retraining (Behavioral)
Sham TDCS + Active Retraining
0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
干预措施: Sham transcranial direct current stimulation (TDCS) (Device)
Sham TDCS + Active Retraining
0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining
干预措施: Nicotine Replacement Therapy (Habitrol) (Drug)
Active TDCS + Sham retraining
2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
干预措施: Sham Retraining (Behavioral)
Active TDCS + Sham retraining
2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
干预措施: Active transcranial direct current stimulation (TDCS) (Device)
Active TDCS + Sham retraining
2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
干预措施: Nicotine Replacement Therapy (Habitrol) (Drug)
Sham TDCS + Sham Retraining
0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
干预措施: Sham Retraining (Behavioral)
Sham TDCS + Sham Retraining
0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
干预措施: Sham transcranial direct current stimulation (TDCS) (Device)
Sham TDCS + Sham Retraining
0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining
干预措施: Nicotine Replacement Therapy (Habitrol) (Drug)
结局指标
主要结局
Cigarettes per Smoking Day
时间窗: 11-Weeks Post-transcranial direct current stimulation (TDCS)/Retraining
Number of cigarettes consumed per day will be assessed using the Timeline Follow-back method to obtain the number of cigarettes consumed on each day since the last administration of the Timeline Follow-back. Cigarettes per smoking day will be the mean number of cigarettes consumed on days on which cigarettes were consumed.
次要结局
- Approach Bias Towards Cigarettes (Measure of response time differences)(1 week Post-transcranial direct current stimulation (TDCS)/Retraining)