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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2023-07-30

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.

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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.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Investigational Device

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.

Group Type ACTIVE_COMPARATOR

HWBV chair

Intervention Type DEVICE

vibration-actuated, saddle-seat type stool

Control Device

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.

Group Type SHAM_COMPARATOR

HWBV chair

Intervention Type DEVICE

vibration-actuated, saddle-seat type stool

Interventions

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HWBV chair

vibration-actuated, saddle-seat type stool

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No