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

NCT05056753 | Completed FDA Device

• 2 other identifiers: CT2101R41DA053083-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Keywords

Opioid-use Disorder; Addiction, Opioid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Opiate Withdrawal Scale (COWS)

  4 weeks

Other Outcomes (3)

• Physiologic Assessment: Galvanic skin response (GSR)

  4 weeks

• Physiologic Assessment: Heart rate (HR)

  4 weeks

• Physiologic Assessment: Heart rate variability (HRV)

  4 weeks

Study Arms (2)

Investigational Device

ACTIVE COMPARATOR

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

Control Device

SHAM COMPARATOR

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

Interventions

HWBV chair DEVICE

vibration-actuated, saddle-seat type stool

Control Device; Investigational Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PhotoPharmics, Inc.: lead
• Brigham Young University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Migraine and Neuro Rehab Clinic

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: September 27, 2021
• Study Start: January 20, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 30, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)