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Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Primary Purpose

Opioid Use Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bridge™ active device
Bridge™ sham device
Sponsored by
Masimo Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Caron Treatment Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Bridge™ active device

Bridge™ sham device

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assess change in Clinical Opiate Withdrawal Scale (COWS) score

Secondary Outcome Measures

Assess change in Subjective Opiate Withdrawal Scale (SOWS) score

Full Information

First Posted
June 21, 2023
Last Updated
June 21, 2023
Sponsor
Masimo Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05924945
Brief Title
Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bridge™ active device
Arm Type
Active Comparator
Arm Description
The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Arm Title
Bridge™ sham device
Arm Type
Sham Comparator
Arm Description
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
Intervention Name(s)
Bridge™ active device
Intervention Description
Bridge is a percutaneous nerve field stimulation device
Intervention Type
Device
Intervention Name(s)
Bridge™ sham device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess change in Clinical Opiate Withdrawal Scale (COWS) score
Time Frame
pre-device placement to Day 5 (post-device removal)
Secondary Outcome Measure Information:
Title
Assess change in Subjective Opiate Withdrawal Scale (SOWS) score
Time Frame
pre-device placement to Day 5 (post-device removal)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Caron Treatment Centers
City
Wernersville
State/Province
Pennsylvania
ZIP/Postal Code
19565
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

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