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

NCT05056753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-10-04

No results posted yet for this study

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

Interventions

DEVICE

HWBV chair

vibration-actuated, saddle-seat type stool

Sponsors & Collaborators

  • Brigham Young University

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • PhotoPharmics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2023-06-01
Completion
2023-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056753 on ClinicalTrials.gov