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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
vibration-actuated, saddle-seat type stool
Migraine and Neuro Rehab Clinic
Provo, Utah, United States
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
Time frame: 4 weeks
Clinical Opiate Withdrawal Scale (COWS)
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
Time frame: 4 weeks
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