Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms (NCT05924945) | Clinical Trial Compass
TerminatedNot Applicable
Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms
Stopped: Sponsor Decision
United States13 participantsStarted 2023-06-08
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Timeframe: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use