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Completed

NCT Number: NCT05056753

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

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Migraine and Neuro Rehab Clinic

Provo, Utah, 84604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HWBV chair

Device

vibration-actuated, saddle-seat type stool

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

PhotoPharmics, Inc.

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2021
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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