Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

NCT05924945 | Terminated Results FDA Device

• 1 other identifier: DENE0001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score

  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 Outcomes (1)

• Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score

  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

Study Arms (2)

Bridge™ active device

ACTIVE COMPARATOR

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

Device: Bridge™ active device

Bridge™ sham device

SHAM COMPARATOR

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

Interventions

Bridge™ active device DEVICE

Bridge is a percutaneous nerve field stimulation device

Bridge™ active device

Bridge™ sham device 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.

Bridge™ sham device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Caron Treatment Centers

Wernersville, Pennsylvania, 19565, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

The study was terminated prematurely due to sponsor decision with no clinical rationale for termination. This prospective study investigated a test device deemed "end-of-life" by the manufacturer. Only 13 subjects used devices of 48 anticipated; 6 subjects completed the study (3 with active device, 3 with shame device). We reported all demographic data and outcome measure data from the limited sample size. Further data reporting would be statistically inappropriate due to the sample size.

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

9492977000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: June 8, 2023
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2025-10

Locations

US (1)