Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms
Not Applicable
Completed
- Conditions
- Opioid Use Disorder
- 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
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
- 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
Caron Treatment Centers🇺🇸Wernersville, Pennsylvania, United States