Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

October 13, 2025 updated by: Masimo Corporation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wernersville, Pennsylvania, United States, 19565
        • Caron Treatment Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bridge™ active device
The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Device: Bridge™ active device
Bridge is a percutaneous nerve field stimulation device
Sham Comparator: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Time Frame: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use

The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Score Range: The COWS score can range from 0 to 48.

Interpretation:

0-4: No withdrawal 5-12: Mild withdrawal 13-24: Moderate withdrawal 25-36: Moderately severe withdrawal 37-48: Severe withdrawal High scores mean more severe withdrawal.
prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Time Frame: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use

The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64.

High scores mean worse symptom intensity.
prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Actual)

August 19, 2024

Study Completion (Actual)

August 19, 2024

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Estimated)

October 28, 2025

Last Update Submitted That Met QC Criteria

October 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DENE0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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