Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Sponsor

Masimo Corporation (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05924945

Collaborator

(none)

Enrollment

Location

Arms

23.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Device: Bridge™ active device Device: Bridge™ sham device	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 8, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Assess change in Clinical Opiate Withdrawal Scale (COWS) score [pre-device placement to Day 5 (post-device removal)]

Secondary Outcome Measures

Assess change in Subjective Opiate Withdrawal Scale (SOWS) score [pre-device placement to Day 5 (post-device removal)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caron Treatment Centers	Wernersville	Pennsylvania	United States	19565

Sponsors and Collaborators

Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Masimo Corporation

ClinicalTrials.gov Identifier:

NCT05924945

Other Study ID Numbers:

DENE0001

First Posted:

Jun 29, 2023

Last Update Posted:

Jun 29, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Opioid-Related Disorders

Study Results

No Results Posted as of Jun 29, 2023