A Pilot Study to Evaluate Safety and Efficacy of a Novel Electrode Configuration for Delivering Transcutaneous Auricular Neurostimulation 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
- 6
- 试验地点
- 2
- 主要终点
- Clinical opiate withdrawal scale (COWS) score
研究概览
简要总结
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
详细描述
This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment. Use of opioid-based medication assisted therapy (MAT) will not be permitted at any point during the study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute COWS assessment to ensure changes in COWS score at 60 minutes are only the result of tAN therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
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 consent 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., pacemakers, cochlear prosthesis, neurostimulators)
- •Abnormal ear anatomy or ear infection present
- •Women of childbearing potential not using adequate contraception as per investigator judgement 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 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) score(Days 2-5)