Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms

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.

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)