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

Completed · Not applicable

Conditions studied: Opioid-use Disorder

In brief

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.

Key facts

Study ID

NCT05056753

Run by

PhotoPharmics, Inc.

People needed

80

Starts

2022-01-20

Expected to finish

2023-07-30

Last updated by the study team

2023-10-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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