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

PhotoPharmics

Status: Completed

Conditions: Opioid-use Disorder

Treatments: Device: HWBV chair

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05056753

R41DA053083-01A1 (U.S. NIH Grant/Contract)

CT2101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Investigational Device

Active Comparator group

Description:

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.

Treatment:

Device: HWBV chair

Control Device

Sham Comparator group

Description:

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.

Treatment:

Device: HWBV chair