Delivering Transcutaneous Auricular Neurostimulation (tAN) to Improve Symptoms Associated With Opioid Withdrawal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Clinical opiate withdrawal scale (COWS) score
研究概览
简要总结
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate device.
详细描述
Prior evidence has demonstrated that non-invasive neurostimulation can modulate specific brains regions associated with opioid use disorder and reduce opioid withdrawal symptoms. This is a double blind, randomized, controlled, multi-center study in which subjects will be randomized in a 1:1 ratio to one of two groups: 1) active transcutaneous auricular neurostimulation (tAN) or 2) delayed-active tAN to determine reduction of symptoms related to opioid withdrawal. Subjects in the active tAN group will receive tAN immediately whereas those in the delayed-active tAN will have their therapy turned on after a 30 minute delay (inactive period). All subjects will be informed of their group assignment at the conclusion of the randomized, double blind period (following initial 30 minutes of active or inactive therapy) and all will continue to receive active tAN throughout the five-day study. Each clinical site will have pre-determined and qualified clinical opiate withdrawal scale (COWS) accessor(s) that will be blind to the subjects group designation during the randomized, double blind period and will not be informed that all subjects receive active therapy throughout the remainder of the study. This will ensure a non-biased assessment of the COWS score and maintain single blinding throughout the duration of the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Current opioid dependence; prescriptive or non-prescriptive
- •COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
- •18-65 years of age
- •English Proficiency
- •Participants must be able to provide informed con-sent and function at an intellectual level sufficient for study requirements
排除标准
- •Current evidence of an uncontrolled and/or clinically significant medical condition
- •History of seizures or epilepsy
- •History of neurological diseases or traumatic brain injury
- •Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
- •Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
- •Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators
- •Abnormal ear anatomy or ear infection present
- •Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
- •Females who are pregnant or lactating
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
结局指标
主要结局
Clinical opiate withdrawal scale (COWS) score
时间窗: 60 minutes
Mean percent change in clinical opiate withdrawal scale (COWS) score from baseline to 60 minutes after start of active tAN therapy. The COWS is an 11-item scale with a score range between 0 and 48. Total score is the sum of all the items and a higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant.
次要结局
- Clinical opiate withdrawal scale (COWS) responder rate(30 minutes)
- Clinical opiate withdrawal scale (COWS) score(Days 2-5)