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

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056753
• Other study ID #: CT2101
• Secondary ID: R41DA053083-01A1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: October 2023
• Source: PhotoPharmics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Device:
• HWBV chair
vibration-actuated, saddle-seat type stool

Locations

Country	Name	City	State
United States	Migraine and Neuro Rehab Clinic	Provo	Utah

Sponsors (3)

Lead Sponsor	Collaborator
PhotoPharmics, Inc.	Brigham Young University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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