Heterodyned Whole-Body Vibration in Treatment of Opioid Withdrawal-Induced Anxiety
Opioid-use Disorder
About this trial
This is an interventional treatment trial for Opioid-use Disorder focused on measuring Opioid-use Disorder, Addiction, Opioid
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
Sites / Locations
- Migraine and Neuro Rehab Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Investigational Device
Control Device
The HWBV chair consists of a custom-made saddle-seat type of chair. The vibration actuators are embedded into the underside design of the chair. The base contains two vibrators, one for each side of the chair, and the chair is split in half vertically so that the vibrating actuators are able to send a harmonic vibration at alternating frequencies, upwards through each side of the chair. The HWBV system is considered a non-significant and non-substantial risk device.
The Control device is identical in construction to the Active device. The vibration mode, however, is a significantly different setting than that used by the Active version, so that the mechanoreceptors in the cervical spine are not effectively stimulated.