Opioid Use DisorderNCT05924945

Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

A study testing Bridge™ active device in people with Opioid Use Disorder, run by Masimo Corporation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Opioid Use Disorder
What is being tested?: Bridge™ active device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2023to 19 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Caron Treatment Centers
Wernersville, Pennsylvania, 19565

Other trials in United States

About this study

Official title: 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.

Conditions: Opioid Use Disorder
Being tested: Bridge™ active device, Bridge™ sham device
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bridge™ active deviceDevice
Bridge is a percutaneous nerve field stimulation device
Bridge™ sham deviceDevice
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.

Study groups in NCT05924945
Study group	Role	What they receive
Bridge™ active device	Active comparator	The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Receives: 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 Receives: Device: Bridge™ sham device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202319 Aug 2024

First posted29 Jun 2023
Study start8 Jun 2023
Primary completion19 Aug 2024
Study completion19 Aug 2024

Why it stopped: Sponsor Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05924945
Sponsor's protocol ID: DENE0001
Status last verified: Oct 2025
First submitted: 21 Jun 2023
Last updated: 28 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Bridge™ Device as a Non-pharmacological Approach to Treat Opioid Withdrawal in Opioid Use Disorder (OUD) Subjects in an Inpatient Treatment Center
ClinicalTrials.gov ID: NCT05924945
Acronym / sponsor ID: DENE0001
Conditions: Opioid Use Disorder
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor Decision
Enrolment: 13 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 8 Jun 2023 (actual)
Primary completion: 19 Aug 2024 (actual)
Study completion: 19 Aug 2024 (actual)
First posted: 29 Jun 2023 (actual)
Results: Posted 28 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bridge™ active device	Active comparator	Device: Bridge™ active deviceThe active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Bridge™ sham device	Sham comparator	Device: Bridge™ sham deviceThe sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bridge™ active deviceBridge is a percutaneous nerve field stimulation device	Device	Bridge™ active device
Bridge™ sham deviceThe 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

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 28 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bridge™ Active Device	6	3
Bridge™ Sham Device	7	3

Primary outcome: 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. Number. Unit: score on a scale

Measure	Bridge™ Active Device n = 3	Bridge™ Sham Device n = 3
Subject 1 COWS score pre-device placement, 0 min device use (raw data)	–	18
Subject 1 COWS score device use 30 min (raw data)	–	5
Subject 1 COWS score device use 60 min (raw data)	–	3
Subject 1 COWS score device use 120 min (raw data)	–	6
Subject 1 COWS score device use 2 days (raw data)	–	10
Subject 1 COWS score device use 3 days (raw data)	–	8
Subject 1 COWS score device use 4 days (raw data)	–	0
Subject 1 COWS score device use 5 days (raw data)	–	7

Population analysed: The study was terminated prematurely due to sponsor decision with no clinical rationale for the termination. This was a prospective study investigating the test device. Of 13 subjects using the device, only 6 completed the study. The sample size is well below the threshold needed to perform reliable statistical comparisons. We reported all demographic data and outcome measure data from the limited sample. Further data reporting would be statistically inappropriate due to the sample size.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through end of study participation (approximately 3 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bridge™ Active Device	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Bridge™ Sham Device	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bridge™ active device in people with Opioid Use Disorder, run by Masimo Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05924945.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.