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Procedure
Bridge™ Device for Opioid Withdrawal
N/A
Waitlist Available
Research Sponsored by Masimo Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-device placement to day 5 (post-device removal)
Awards & highlights
Study Summary
This trial will test a device to see if it can reduce opioid withdrawal symptoms, compared to a fake device.
Who is the study for?
This trial is for adults aged 18-65 with opioid use disorder (OUD) who can consent to participate and are entering an OUD treatment program. It's not for those needing tapering from other substances, involved in recent trials, with open wounds/infections like MRSA, serious medical conditions, pregnant or lactating women, certain skin diseases or irritated skin where the device goes, severe autoimmune disease or uncontrolled diabetes, psychiatric illnesses including bipolar disorder or schizophrenia.Check my eligibility
What is being tested?
The study tests the Bridge™ device's ability to ease opioid withdrawal symptoms against a sham (fake) version of the device. Participants won't know which one they're getting as it's a blind comparison meant to measure how effective the real Bridge™ device is.See study design
What are the potential side effects?
Potential side effects aren't specified here but could include discomfort at the site of placement if you have sensitive skin or an allergic reaction to materials in either version of the Bridge™ device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-device placement to day 5 (post-device removal)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-device placement to day 5 (post-device removal)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess change in Clinical Opiate Withdrawal Scale (COWS) score
Secondary outcome measures
Assess change in Subjective Opiate Withdrawal Scale (SOWS) score
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Bridge™ active deviceActive Control1 Intervention
The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Group II: Bridge™ sham devicePlacebo Group1 Intervention
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
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Who is running the clinical trial?
Masimo CorporationLead Sponsor
112 Previous Clinical Trials
13,077 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an open wound, abscess, or MRSA infection.I have experienced chronic pain for the last 3 months.I have a psychiatric condition like bipolar disorder, schizophrenia, or have had recent suicidal thoughts or attempts.I have a severe autoimmune disease or my diabetes is not under control.I have irritated or broken skin where the device will be placed.I have a history of wounds healing poorly.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Bridge™ active device
- Group 2: Bridge™ sham device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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