BRIDGE Device for Symptoms of Opioid Withdrawal: A Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Comparison of change from baseline of Clinical Opiate Withdrawal Scale (COWS) scores between active BRIDGE device group and sham BRIDGE device group at one hour
研究概览
简要总结
The purpose of this study is to prospectively evaluate the effectiveness of the NSS-2 BRIDGE device in reducing the signs and symptoms of acute opioid withdrawal when compared to placebo.
详细描述
The BRIDGE device is a novel, non-pharmacological, non-invasive, auricular percutaneous electrical nerve field stimulator (PENFS) that is thought to significantly reduce pain and modulate the autonomic nervous system through application to branches of Cranial Nerves V, VII, IX, and X, as well as branches of the occipital nerves identified by transillumination. The novelty of this device is in the use of alternating current and higher voltage stimulation over a large field in the external ear that allows access into central brain regions involved in fear and pain modulation. This device has been approved by the United States Food and Drug Administration (FDA) to treat the symptoms of opioid withdrawal.
In this study, the BRIDGE device will be compared to a "sham" (inactive) device. The sham device will be identical in appearance to the active device but will have no electrical current. Neither the patient or the study doctor/study staff will know whether an active or inactive device is being used during the study (double-blind).
The effectiveness of the device in reducing signs and symptoms of opioid withdrawal will be measured by:
- Assessing the severity of opioid withdrawal symptoms pre and post device placement for a period of 5 days.
- Assessing improvements in pain, craving and cognition pre and post device placement for a period of 5 days.
The investigators hypothesize that treatment with the BRIDGE device will have a significant and profound effect on decreasing opioid withdrawal scores compared to sham. The investigators also hypothesize that the BRIDGE device will have a significant and profound effect on decreasing pain and craving scores quickly in the two hours following application as well as the ensuing 4-5 days, and will demonstrate improvement in memory and executive function compared to sham treatment.
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
Patients will be randomly assigned to one of the 2 treatment groups in equal ratio. Randomization will be done centrally using a randomized block design, with blocks of 4 using the Pqantadosi Randomization software. There will be a randomization table provided to the person dispensing the devices. The unblinded, lead research coordinator will keep the data in a secure database and will not be involved in any of the patient recruitment or study procedures. All other research coordinators, investigators, and nurses involved will be blinded to group allocation. In general, the study biostatisticians and the person dispensing will be the only people un-blinded throughout the duration of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be 18 years or older who speak English and meet criteria for opioid use disorder based on the Diagnostic and Statistical Manual of Mental Disorders-5.
排除标准
- 未提供
结局指标
主要结局
Comparison of change from baseline of Clinical Opiate Withdrawal Scale (COWS) scores between active BRIDGE device group and sham BRIDGE device group at one hour
时间窗: 3 months
The primary outcome is comparison of change from baseline of the Clinical Opiate Withdrawal Scale (COWS) scores( score: 5-12=Mild; 13-24=Moderate; 25-36=Moderately Severe; More than 36=Severe Withdrawal) between active BRIDGE device group and sham BRIDGE device group at one hour. The two groups will be compared using a two-sided two sample t-test at an alpha of 0.001 at an interim analysis of the first 24 completing and at an alpha of 0.049 after 50 have completed. For all the efficacy parameters (e.g. Clinical Opiate Withdrawal Scale, Visual Analog Scale, Opioid Craving Scale and the Stroop test using CNS Vital Signs) the descriptive statistics will include N, mean median, standard error (SE), minimum and maximum or percentage and exact Clopper Pearson 95% confidence interval.
次要结局
- Comparison of change from baseline of Clinical Opiate Withdrawal Scale (COWS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months(3 months)
- Comparison of change from baseline of Opioid Craving Scale (OCS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months(3 months)
- Comparison of change from baseline of pain Visual Analog Scale (VAS) scores between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months(3 months)
- Comparison of change from baseline of cognition Stroop test scores using CNS Vital Signs software between active BRIDGE device group and sham BRIDGE device group over time for up to 3 months(3 months)