Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms
Opioid Use Disorder
About this trial
This is an interventional treatment trial for Opioid Use Disorder
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)
Sites / Locations
- Caron Treatment Centers
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Bridge™ active device
Bridge™ sham device
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