Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2024-08-19

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.

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Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

A randomization table will be kept with the sponsor. Subjects and study site staff (investigators, researchers, care providers) will be blinded to the group assignment.

Study Groups

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Bridge™ active device

The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.

Group Type ACTIVE_COMPARATOR

Bridge™ active device

Intervention Type DEVICE

Bridge is a percutaneous nerve field stimulation device

Bridge™ sham device

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

Group Type SHAM_COMPARATOR

Bridge™ sham device

Intervention Type DEVICE

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.

Interventions

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Bridge™ active device

Bridge is a percutaneous nerve field stimulation device

Intervention Type DEVICE

Bridge™ sham device

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.

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No