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

Not Applicable

Completed

• Conditions: Opioid-use Disorder

• Registration Number: NCT05056753
• Lead Sponsor: PhotoPharmics, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-27
• Study Start: 2022-01-20
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale (HAM-A)	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

Secondary Outcome Measures

Name	Time	Method
Clinical Opiate Withdrawal Scale (COWS)	4 weeks	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

Trial Locations

Locations (1)

Migraine and Neuro Rehab Clinic; 🇺🇸 Provo, Utah, United States