Clinical trial NCT05056753: Heterodyned Whole-Body Vibration in Treatment of Opioid Withdrawal-Induced Anxiety
Official title: Amerlioration of Opioid Withdrawal-Induced Anxiety and Craving With Heterodyned Whole-Body Vibration (HWBV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Opioid-use Disorder
Addiction, Opioid
Lead sponsor: PhotoPharmics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Brigham Young University
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 4 weeks
Secondary outcomes:
measure: Clinical Opiate Withdrawal Scale (COWS)
timeFrame: 4 weeks
Other outcomes:
measure: Physiologic Assessment: Galvanic skin response (GSR)
timeFrame: 4 weeks
measure: Physiologic Assessment: Heart rate (HR)
timeFrame: 4 weeks
measure: Physiologic Assessment: Heart rate variability (HRV)
timeFrame: 4 weeks
Locations:
city: Provo
country: United States
facility: Migraine and Neuro Rehab Clinic
state: Utah
Study officials:
References: