Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
研究概览
简要总结
The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.
详细描述
This is a prospective observational clinical trial in which 20 participants with a history of dependence on prescription or non-prescription opioids will be recruited for collection of physiologic data via wearable sensors during a 14-day inpatient detoxification treatment. The EmbracePlus Smartwatch and Corti Sensor will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Participant has a recent history of opioid dependence; prescription or non-prescription
- Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)
- Participant is between 18 and 50 years of age
- Participant is English proficient
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
- Participant is willing to wear wearable sensors for 14 days
排除标准
- Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
- Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial
- Females who are pregnant or lactating
- Participant has 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
研究组 & 干预措施
Opioid Use Disorder
Participants with a history of dependence on prescription or non-prescription opioids
干预措施: Corti Sensor (Device)
Opioid Use Disorder
Participants with a history of dependence on prescription or non-prescription opioids
干预措施: EmbracePlus Smartwatch (Device)
结局指标
主要结局
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
时间窗: Daily throughout the 14-day inpatient detoxification treatment
Correlation of opioid withdrawal symptoms, as measured by the SOWS-Gossop, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Opioid Craving Visual Analog Scale (OC-VAS)
时间窗: Daily throughout the 14-day inpatient detoxification treatment
Correlation of the intensity of opioid cravings, as measured by the OC-VAS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Adverse Events
时间窗: Daily throughout the 14-day inpatient detoxification treatment
The primary safety endpoint will be the proportion of participants who experience one or more adverse events.
Clinical Opioid Withdrawal Scale (COWS)
时间窗: Daily throughout the 14-day inpatient detoxification treatment
Correlation of opioid withdrawal symptoms, as measured by the COWS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
次要结局
未报告次要终点
研究者
研究点 (4)
标识符
- NCT 编号
- NCT06487533
- 其他研究编号
- SBM-OWP-09, 1R43DA059448
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (6个月后)
- 研究完成日期
- (8个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否