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

October 3, 2023 updated by: PhotoPharmics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: 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
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Opiate Withdrawal Scale (COWS)
Time Frame: 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
4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physiologic Assessment: Galvanic skin response (GSR)
Time Frame: 4 weeks
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)
Time Frame: 4 weeks
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)
Time Frame: 4 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PhotoPharmics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Brigham Young University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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