Amerlioration of Opioid Withdrawal-Induced Anxiety and Craving With Heterodyned Whole-Body Vibration (HWBV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hamilton Anxiety Rating Scale (HAM-A)
研究概览
简要总结
In this randomized, double-blind, controlled, parallel group study (conducted over 12-months), enrollment is expected of up to 60 subjects (30 men and 30 women) ages 18+ who are currently going through withdrawal of OUD and being treated at local substance abuse clinics. The study visits will include screening, baseline, Weeks 1, 2, 3, and 4, with both safety and efficacy assessments.
详细描述
Approximate time commitment is 30 minutes / day, for 5 days / week, in testing effects of specialized 'massage' chair for a period of 4 weeks (up to total 20 treatment periods). Only about 20 minutes time is in the test chair, and the rest is setup time and completing questionnaires.
- Upon arrival to the clinic for treatment, some short questions are asked.
- Participant is seated in a HWBV chair device.
- A clip is attached to one finger to track heart rate and skin response to the treatment.
- After relaxing for about 5 minutes, the HWBV chair actuated for 10 minutes.
- The finger attachment is disconnected.
- Post-treatment, some more survey questions conclude the session.
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
Participants will spend approx 30 min/day for 5 days/week in HWBV testing for the 4-week treatment period at the treatment clinic. Eligible participants who consent to the study are screened and randomized to either the active or control group, using the vibration device with controller that has 2 unmarked presets as to which treatment protocol they represent (HWBV or monotonic vibration). Neither the study coordinator, technician, nor site investigator will know which setting is the active or control. The device technician (blinded to the treatment hypothesis) will help participants set up the device and provide assistance. To avoid unblinding, device technician will be segregated from all study personnel and data. He/she will also be instructed not to comment to the patients on any aspects of the device and defer study related questions to the study staff. A blinded coordinator / staff member will conduct study assessments at baseline, weeks 1, 2, 3, and 4, visits.
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
- •Minimum age of 18 (female and male)
- •Confirmed diagnosis of opioid use disorder and deemed appropriate to participate in this study as referred by the medial director of a local outpatient treatment clinic for OUD
- •Concurrent craving for drug
- •In otherwise good physical health
- •Access to a phone (communication device) and willingness to communicate with study staff
- •Ability to understand and provide informed consent in English
排除标准
- •Inability to provide verifiable contact information or unwillingness to assist with follow-up
- •Unwilling to allow potential access to medical, drug treatment records or criminal history or criminal activity records that in the opinion of the site investigator would interfere with the conduct of the study
- •History of violence or violent, erratic behavior that would indicate a risk to other participants, study staff or to the participant her/himself
- •Psychoses, major depression, bipolar disorder, or other mental disorder that in the opinion of the site investigator, would interfere with the participant's ability to participate in the study
- •A score of > 2 on the Beck Depression Inventory-II (BDI-II) [Suicidality]
- •A score of < 6 on the Clinical Opiate Withdrawal Scale, which indicates mild opiate withdrawal symptoms
- •Prior history of severe brain injury or seizures
- •Prone to fainting
- •Suffering from a recent injury from which they are still recovering or needing medications for recovery
- •Not have used opiates within the last 24 hours or longer than the past 60 days
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: 4 weeks
The Hamilton Anxiety Rating Scale (HAM-A) measures severity of anxiety, with 14 domains and is administered by a clinician. Severity is rated from 0 - 4 on each question, with a total possible of 56 points. A higher score is reflects worse severity
次要结局
- Clinical Opiate Withdrawal Scale (COWS)(4 weeks)