Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Not Applicable

Completed

• Conditions: Opioid Use Disorder
• Interventions: Device: Bridge™ sham device; Device: Bridge™ active device

• Registration Number: NCT05924945
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-08
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-06-29
• Primary Completion: 2024-08-19
• Study Completion: 2024-08-19
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bridge™ sham 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
Bridge™ active device	Bridge™ active device	The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Caron Treatment Centers; 🇺🇸 Wernersville, Pennsylvania, United States