Opioid-use Disorder
Conditions
Keywords
Opioid-use Disorder, Addiction, Opioid
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.
Interventions
DEVICEHWBV chair
vibration-actuated, saddle-seat type stool
Sponsors
Brigham Young University
National Institute on Drug Abuse (NIDA)
PhotoPharmics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will spend approx 30 min/day for 5 days/week in HWBV testing for the 4-week treatment period at the treatment clinic. Eligible participants who consent to the study are screened and randomized to either the active or control group, using the vibration device with controller that has 2 unmarked presets as to which treatment protocol they represent (HWBV or monotonic vibration). Neither the study coordinator, technician, nor site investigator will know which setting is the active or control. The device technician (blinded to the treatment hypothesis) will help participants set up the device and provide assistance. To avoid unblinding, device technician will be segregated from all study personnel and data. He/she will also be instructed not to comment to the patients on any aspects of the device and defer study related questions to the study staff. A blinded coordinator / staff member will conduct study assessments at baseline, weeks 1, 2, 3, and 4, visits.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Rating Scale (HAM-A) | 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Opiate Withdrawal Scale (COWS) | 4 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physiologic Assessment: Galvanic skin response (GSR) | 4 weeks | Physiologic measures of Galvanic skin response (GSR), will be measured during the 5-minute pre-, the 10-minute seated vibration session, and 5-minute post-vibration in the chair (device technician will then remove the finger plethysmograph). |
| Physiologic Assessment: Heart rate (HR) | 4 weeks | Physiologic measures of heart rate (HR), will be measured during the 5-minute pre-, the 10-minute seated vibration session, and 5-minute post-vibration in the chair (device technician will then remove the finger plethysmograph). |
| Physiologic Assessment: Heart rate variability (HRV) | 4 weeks | Physiologic measures of heart rate variability (HRV), will be measured during the 5-minute pre-, the 10-minute seated vibration session, and 5-minute post-vibration in the chair (device technician will then remove the finger plethysmograph). |
Countries
United States
Outcome results
None listed