Heterodyned Whole-Body Vibration in Treatment of Opioid Withdrawal-Induced Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Amerlioration of Opioid Withdrawal-Induced Anxiety and Craving With Heterodyned Whole-Body Vibration (HWBV)

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Device: HWBV chair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a 4-week, randomized, double-blind, controlled, parallel group study with 5 visits; at screening/baseline, and weeks 1-4 and daily visits to the treatment clinic, with blinded evaluation of efficacy and safety assessments.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigational Device<br>The HWBV chair consists of a custom-made saddle-seat type of chair. The vibration actuators are embedded into the underside design of the chair. The base contains two vibrators, one for each side of the chair, and the chair is split in half vertically so that the vibrating actuators are able to send a harmonic vibration at alternating frequencies, upwards through each side of the chair. The HWBV system is considered a non-significant and non-substantial risk device. | Device: HWBV chair<br>* vibration-actuated, saddle-seat type stool<br>|
| Sham Comparator: Control Device<br>The Control device is identical in construction to the Active device. The vibration mode, however, is a significantly different setting than that used by the Active version, so that the mechanoreceptors in the cervical spine are not effectively stimulated. | Device: HWBV chair<br>* vibration-actuated, saddle-seat type stool<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Rating Scale (HAM-A) | 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 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Opiate Withdrawal Scale (COWS) | The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to rate common signs and symptoms of opiate withdrawal to show overall severity of addiction. Each question ranks severity from 0-4 or 5, depending on the question. A higher score indicates greater severity. The COWS to be administered by a clinician | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid-use Disorder, Addiction, Opioid