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

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Device: HWBV chair

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Provo, Utah, United States, 84604
      • Migraine and Neuro Rehab Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: HWBV chair; vibration-actuated, saddle-seat type stool
Sham Comparator: 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.	Device: HWBV chair; vibration-actuated, saddle-seat type stool

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiologic Assessment: Galvanic skin response (GSR)	Physiologic measures of Galvanic skin response (GSR), will be measured during the 5-minute pre-, the 10-minute seated vibration session, and 5-minute post-vibration in the chair (device technician will then remove the finger plethysmograph).	4 weeks
Physiologic Assessment: Heart rate (HR)	Physiologic measures of heart rate (HR), will be measured during the 5-minute pre-, the 10-minute seated vibration session, and 5-minute post-vibration in the chair (device technician will then remove the finger plethysmograph).	4 weeks
Physiologic Assessment: Heart rate variability (HRV)	Physiologic measures of heart rate variability (HRV), will be measured during the 5-minute pre-, the 10-minute seated vibration session, and 5-minute post-vibration in the chair (device technician will then remove the finger plethysmograph).	4 weeks

Collaborators and Investigators

• Sponsor: PhotoPharmics, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Brigham Young University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Opioid-use Disorder; Addiction, Opioid
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: CT2101; R41DA053083-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In addition to submitting the study design and results to www.clinicaltrials.gov, the final results of the study will be published in a peer-reviewed journal after the generation of the clinical study report. Subsequent to publication, PhotoPharmics and Brigham Young University intend to make the data available to qualified researchers for collaboration. The general results of the trial may also be made available to study participants during a webinar.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No