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

  • STATUS
    Recruiting
  • End date
    Oct 16, 2022
  • participants needed
    60
  • sponsor
    PhotoPharmics, Inc.
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Updated on 16 March 2022
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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.

Details
Condition Opioid-use Disorder
Treatment HWBV chair
Clinical Study IdentifierNCT05056753
SponsorPhotoPharmics, Inc.
Last Modified on16 March 2022

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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