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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 weeks
Treatment ~ Varies
Follow Up ~pre-device placement to day 5 (post-device removal)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-device placement to day 5 (post-device removal) for reporting.

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

Find a Location

Who is running the clinical trial?

Masimo CorporationLead Sponsor
111 Previous Clinical Trials
13,024 Total Patients Enrolled

Media Library

Bridge™ Device (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05924945 — N/A
Opioid Use Disorder Research Study Groups: Bridge™ active device, Bridge™ sham device
Opioid Use Disorder Clinical Trial 2023: Bridge™ Device Highlights & Side Effects. Trial Name: NCT05924945 — N/A
Bridge™ Device (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05924945 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to be involved in this scientific experiment?

"Clinicaltrials.gov reflects that this clinical trial is no longer seeking participants, the protocol of which was initially published on June 8th 2023 and last modified on June 21st 2023. Despite this, there are 298 other medical studies actively recruiting at present."

Answered by AI

Could I be considered for enrollment in this research study?

"Eligibility for this trial is based on being diagnosed with opioid use disorder and a chronological age between 18-65. A total of 48 participants will be recruited to participate in the study."

Answered by AI

Is participation permissible for adults aged eighteen or older in this clinical research?

"This clinical trial is inviting participants that are of legal age and younger than 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms
2023. "Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05924945.
~27 spots leftby Jun 2025
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