Pilot Evaluation of the Empower Neuromodulation System in Alcohol Use Disorder (AUD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Mean Number of Alcoholic Drinks Consumed Per Day
研究概览
简要总结
This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD). This is a pilot investigation in which all participants will receive the active treatment.
详细描述
Alcohol use disorder (AUD) is a major public health concern, affecting over 16 million Americans. Peripheral nerve stimulation via acupuncture has been shown to directly decrease alcohol craving and self-administration. TheraNova has developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of AUD. In this study, we will conduct a cross-over, home-use study in participants with AUD. Participants will have a one-week control period with no treatment followed by two weeks of twice daily treatment with the Empower device. We will evaluate endpoints for safety and effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is male or female ≥ 21 year of age at Visit 1
- •Has a current diagnosis of alcohol use disorder per DSM-5 by clinician assessment
- •Endorses Criterion 4 in DSM-5
- •Has a desire to maintain abstinence or, if not abstinent, a desire to reduce or quit alcohol use
- •Has a breath alcohol concentration of 0.00% at enrollment
- •Is able to provide informed consent
- •Is able to understand spoken and written English
- •Is capable and willing to follow all study-related procedures
排除标准
- •Has been diagnosed with unstable psychosis, epilepsy, peripheral neuropathy, or nerve damage
- •Requires acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD)
- •Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
- •Has an electrically conductive metal object (e.g. jewelry) that cannot be removed from the palm and will directly contact the gel electrodes of the Empower Neuromodulation System
- •Will not, for the duration of the participation in the study, have a living situation that provides regular access to an electrical outlet.
- •Is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- •Has used an investigational drug/device therapy within the past 4 weeks
- •Is deemed unsuitable for enrollment in the study by the PI
结局指标
主要结局
Change in Mean Number of Alcoholic Drinks Consumed Per Day
时间窗: Baseline week and Week 2 of the treatment phase
Change in the self-reported average daily consumption over the final week (Week 2) of the treatment phase compared to the week of the pre-treatment baseline phase.
Number of Participants With Adverse Events
时间窗: Through study completion, an average of 3 weeks
Safety assessment via device-related adverse events
次要结局
- Decrease in Mean Alcohol Craving Intensity(Baseline week and Week 2 of the treatment phase)
- Usability(Study completion, at approximately 3 weeks)