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

Primary Purpose

Opioid-use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HWBV chair

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Opioid-use Disorder, Addiction, Opioid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Migraine and Neuro Rehab Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Investigational Device

Control Device

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05056753

First Posted

June 25, 2021

Last Updated

October 3, 2023

Sponsor

PhotoPharmics, Inc.

Collaborators

Brigham Young University, National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT05056753

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

January 20, 2022 (Actual)

Primary Completion Date

June 1, 2023 (Actual)

Study Completion Date

July 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PhotoPharmics, Inc.

Collaborators

Brigham Young University, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder

Keywords

Opioid-use Disorder, Addiction, Opioid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Investigational Device

Arm Type

Active Comparator

Arm Description

Arm Title

Control Device

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

HWBV chair

Intervention Description

vibration-actuated, saddle-seat type stool

Primary Outcome Measure Information:

Title

Hamilton Anxiety Rating Scale (HAM-A)

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Clinical Opiate Withdrawal Scale (COWS)

Description

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

Physiologic Assessment: Galvanic skin response (GSR)

Description

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).

Time Frame

4 weeks

Title

Physiologic Assessment: Heart rate (HR)

Description

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).

Time Frame

4 weeks

Title

Physiologic Assessment: Heart rate variability (HRV)

Description

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).

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Migraine and Neuro Rehab Clinic

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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