Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

Masimo

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Device: Bridge™ active device; Device: Bridge™ sham device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05924945

DENE0001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups

Bridge™ active device

Active Comparator group

Description:

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

Treatment:

Device: Bridge™ active device

Bridge™ sham device

Sham Comparator group

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

Treatment:

Device: Bridge™ sham device