NCT02570763撤回不适用
Combining Non-Invasive Brain Stimulation With Cognitive Behavioral Intervention in Substance Use Disorder
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Therapy Content Memory Assessment
研究概览
简要总结
The current study aims to examine the safety and feasibility of utilizing tDCS to enhance affect-laden episodic memory consolidation among adults with co-occurring alcohol use and anxiety disorders who have recently undergone detoxification as a step toward the translational clinical application of this approach.
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)
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
- 否
入选标准
- •DSM IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
- •DSM IV diagnosis of alcohol dependence within the last 30 days
- •inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
- •alcohol use in the 30 days preceding the study
- •willingness to provide informed consent
- •minimum of a sixth grade English reading level (deemed necessary to complete study materials); as determined by their being able to read and understand the consent form.
- •Living within reasonable driving distance (1 hour or less) of the Twin Cities to allow for in-person follow-up interviews
排除标准
- •lifetime history of psychosis or mania by history.
- •cognitive (e.g., dementia) or physical impairment (e.g., blindness) that interferes with study participation report or as judged by PI/study physician.
- •Current suicide risk as deemed by the PI and study physician to be serious and ongoing
- •any medical condition or treatment with neurological sequelae (e.g., stroke, tumor, loss of consciousness of more than 30 minutes, HIV, seizures)
- •history of ECT
- •document loss of consciousness (LOC) for longer than 30 minutes or LOC with neurological sequelae
- •pregnancy
- •Although seizures are not a known risk of tDCS intervention (Fregni et al., 2006; Nitsche et al., 2008), anyone with a history or a risk for seizures will be excluded from the study
- •anyone with metal objects implanted in their head or neck
- •anyone taking stimulant medications for any reason as we wish to avoid two sorces of neurostimulation
研究组 & 干预措施
Active Stimulation
Experimental
Active tDCS administration during the first 20 minutes of each of the six therapy sessions.
干预措施: Active tDCS stimulation (Device)
Sham Stimulation
Sham Comparator
Sham tDCS administration during the first 20 minutes of each of six therapy sessions.
干预措施: Sham tDCS stimulation (Device)
结局指标
主要结局
Therapy Content Memory Assessment
时间窗: 24 hours
Participant's will complete daily assessments of their memory for therapy content from the previous session.
次要结局
未报告次要终点
研究者
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