A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Nexalin Electrical Brain Stimulation as an Adjunctive Therapy for Substance Dependence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Treatment response
研究概览
简要总结
The purpose of this research study is to determine whether Nexalin Trans-cranial Electrical Stimulation (TES) is a viable adjunctive treatment of substance use treatments.
详细描述
A Randomized Controlled Trial with block randomization. Inpatient subjects actively seeking substance abuse treatment at the Carrier Clinic who are diagnosed with a substance use disorder, including alcohol use disorder, tobacco use disorder, polysubstance use disorder, or other substance use disorder.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All participants and investigators are blind to condition
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
- •Be able to provide informed consent, assessed by the study clinician
- •Be able to speak, read and write fluently in English, assessed by the study clinician
- •Be committed to completion of the study. The subject will need to attest to availability for 10 to 15 treatments over a 5 to 8 day period for the treatment protocol.
- •Be adults over age 18 and under age 65
- •Be actively receiving substance use treatment for a substance use disorder
排除标准
- •Pregnant or at risk of becoming pregnant
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of the study results, or put the person at undue risk
研究组 & 干预措施
TES Treatment
Where subject is randomized to TES.
干预措施: TES Treatment (Device)
TES-SHAM Treatment
Where subject is randomized to a SHAM condition
干预措施: TES-SHAM Treatment (Device)
结局指标
主要结局
Treatment response
时间窗: 5-8 Days
Reduction in depressive symptoms as a result of Nexalin vs Sham
次要结局
未报告次要终点
研究者
Michael A. Grandner
Assistant Professor of Psychiatry, Psychology, and Medicine Director, Sleep & Health Research Program
University of Arizona