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Behavioural Intervention
Investigational Device for Opioid Use Disorder
N/A
Waitlist Available
Research Sponsored by PhotoPharmics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial is testing a new medication for people withdrawing from opioid addiction. It will enroll up to 60 people, and will last for 12 months.
Eligible Conditions
- Opioid Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hamilton Anxiety Rating Scale (HAM-A)
Secondary outcome measures
Clinical Opiate Withdrawal Scale (COWS)
Other outcome measures
Physiologic Assessment: Galvanic skin response (GSR)
Physiologic Assessment: Heart rate (HR)
Physiologic Assessment: Heart rate variability (HRV)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Investigational DeviceActive Control1 Intervention
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.
Group II: Control DevicePlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Brigham Young UniversityOTHER
22 Previous Clinical Trials
10,142 Total Patients Enrolled
PhotoPharmics, Inc.Lead Sponsor
2 Previous Clinical Trials
392 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,513 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe mental conditions like psychosis, major depression, bipolar disorder, or other mental disorders that could make it difficult for you to take part in the study.You have had a serious brain injury or seizures in the past.You are in good overall physical health.You have mild symptoms of opiate withdrawal, with a score less than 6 on a scale used to measure these symptoms.You have recently been injured and are still healing or taking medications to recover.You have not taken any opiates in the past 24 hours or within the last 60 days.You have a tendency to faint.You currently have a strong desire or urge to use drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Device
- Group 2: Control Device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity for participants in this study?
"Affirmative. The clinical trial's listing on clinicaltrials.gov reveals that it is presently recruiting patients; initial postings were on January 20th 2022 and the last edits took place October 4th 2022. This research requires 60 participants from a single site to take part."
Answered by AI
How many participants are the maximum allowable number for this trial?
"Affirmative. According to the clinicaltrials.gov website, this research project is actively recruiting individuals and was first posted on January 20th 2022 with a last update of October 4th 2022. The requirement for participation stands at 60 patients from 1 location."
Answered by AI
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