Opioid Physiology Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Physiological changes
研究概览
简要总结
The current project seeks to explore the use of emergent biosensor technology to detect opioid use. The investigators goal is to recruit 60 opioid naïve patients presenting at the College of Dentistry at UTHSC. Candidate participants must be scheduled for an upcoming dental procedure that will involve subsequent pain management using oral opioid medication. Participants will be consented prior to any study procedures. All participant information from this study will be kept strictly confidential (e.g., no individual data will be shared with the College of Dentistry).
详细描述
Opioid overdose is a leading cause of accidental death in the USA, with death rates rising steadily over the last 20 years (CDC, 2015). Of the over 22,000 deaths relating to pharmaceutical overdose in 2011, three quarters involved opioid analgesics (Fletcher et al., 2011). Increases in problematic opioid use have paralleled a corresponding increase in drug treatment admissions (DOHH, 2014). Drug treatment programs currently focus on behavioral and pharmacologic interventions to sustain abstinence, and success is typically measured by self-reports or urine drug screening (NIDA, 2016). Both measurement methods are limited by such factors as recall bias, distortion, and lack of precision (Fishman et al., 2000). A detection method that accurately detects opioid use as it occurs in real time would provide several distinct advantages, including the ability to obtain environmental and behavioral contexts surrounding relapse as well as an opportunity for targeted interventions.
The current project seeks to explore the use of emergent biosensor technology to detect opioid use. The investigators goal is to recruit 60 opioid naïve patients presenting at the College of Dentistry at UTHSC. Candidate participants must be scheduled for an upcoming dental procedure that will involve subsequent pain management using oral opioid medication. Participants will be consented prior to any study procedures. All participant information from this study will be kept strictly confidential (e.g., no individual data will be shared with the College of Dentistry).
Participants who are enrolled will complete baseline questionnaires regarding psychological and behavioral risks of substance use. Next, participants will be asked to wear the wristband sensor for 1 day prior to surgery, and up to 30 days post-surgery, or as long as opioid medication is prescribed. Physiological measurement will be conducted via the Empatica E4 wristband biosensor, which measures electrodermal activity, skin temperature, and locomotion data. Opioid use will detected through biosensor activity. Participants will be recruited over a 6 month period, in cohorts of 10. All study procedures will be approved by the UTHSC IRB.
Hilbert transform analyses combined with paired t-tests will be used to compare the biosensor data: (A) within subjects, before and after administration of opioids; and (B) between subjects, controlling for hand dominance, gender, and length of prescription.
Results of analyses will be shared with the College of Dentistry, and will subsequently be disseminated through a peer-reviewed publication.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18 or over)
- •Opioid naive
- •Getting a dental surgery where clinicians will prescribe opioid medication
- •Ability to consent
- •English as primary language
- •Willingness to wear biosensor
- •Willingness to complete daily log
- •Willingness to provide saliva samples (epigenetics)
排除标准
- •Inability to wear biosensor
- •Other cause of pain (that may lead to other opioid use)
- •Current drug or alcohol depend
- •Inability to Consent
- •Pregnancy
- •Incarceration
- •Musculoskeletal causes of pain limiting motion
- •Upper Extremity Amputation
- •Individuals with Developmental Disabilities
结局指标
主要结局
Physiological changes
时间窗: Physiological activity recording will start 24 to 48 hours before dental surgery date. Physiological activity will be stopped 2 days after discontinuation of opioid self-administration and will not exceed 30 days from surgery date.
We will be measuring physiological changes from pre- to post-opioid administration through the Empatica E4 electronic wristband. This device measures 5 physiological parameters: 1. Physical activity through an accelerometer measuring movement on x,y, and z axes. 2. Heart rate measured in beats per minute (BMP) 3. Skin conductance measured in µs (microseconds) 4. Temperature measured in Celsius (°C) 5. Blood volume pulse measured in nm (nanometers) and DNA methylation after self administration of opioid medication.
次要结局
- DNA Methlyation changes(Initial saliva sample will be collected before surgery date. Second sample will be collected 2 days after discontinuation of opioid self-administration. Last sample will be collected at the 30 days from surgery date.)
