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| ID | Type | Description | Link |
|---|---|---|---|
| R41DA053083-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brigham Young University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device | Active Comparator | 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. |
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| Control Device | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HWBV chair | Device | vibration-actuated, saddle-seat type stool |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Assessment: Galvanic skin response (GSR) | 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). | 4 weeks |
| Physiologic Assessment: Heart rate (HR) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Migraine and Neuro Rehab Clinic | Provo | Utah | 84604 | United States |
In addition to submitting the study design and results to www.clinicaltrials.gov, the final results of the study will be published in a peer-reviewed journal after the generation of the clinical study report. Subsequent to publication, PhotoPharmics and Brigham Young University intend to make the data available to qualified researchers for collaboration. The general results of the trial may also be made available to study participants during a webinar.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 7, 2024 | Dec 2, 2024 | 5 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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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.
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). |
| 4 weeks |
| Physiologic Assessment: Heart rate variability (HRV) | 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). | 4 weeks |