Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Study Overview
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Brief Summary
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The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.

Official Title
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Impact of Bridge™ Device as a Non-pharmacological Approach to Treat Opioid Withdrawal in Opioid Use Disorder (OUD) Subjects in an Inpatient Treatment Center

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Device: Bridge™ active device
* Device: Bridge™ sham device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant able to provide written informed consent Participant is 18 to 65-years old Participant has confirmed opioid use disorder (OUD) as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 Participants is entering an OUD treatment program Exclusion Criteria: Participant requires tapering from another substance at entry to treatment Participant is pregnant or lactating Participant has a history of hemophilia or psoriasis vulgaris Participant has a cardiac pacemaker implant device Participant has irritated or broken skin at the site of intended device placement Participant is currently participating in, or was enrolled in another clinical trial within the last 30 days Participant has a history of poor wound healing Participant has a severe autoimmune disease or uncontrolled diabetes Participant has an open wound/abscess infection/MRSA Participant has a history of a chronic pain in the last 90 days Participant has a serious medical condition which in the judgment of the principal investigator or his/her designee would make study participation unsafe, or would make intervention compliance difficult Participant has a psychiatric illness (bipolar disorder, schizophrenia, or other psychotic disorder, active suicidal ideation with a plan within the last month or suicide attempt)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bridge™ active device<br>The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. | Device: Bridge™ active device<br>* Bridge is a percutaneous nerve field stimulation device<br>|
| Sham Comparator: Bridge™ sham device<br>The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses | Device: Bridge™ sham device<br>* The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in Clinical Opiate Withdrawal Scale (COWS) score |  | pre-device placement to Day 5 (post-device removal) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change in Subjective Opiate Withdrawal Scale (SOWS) score |  | pre-device placement to Day 5 (post-device removal) |