← Back to Search

Neuromodulator Medical Device

Bridge Device + Lofexidine for Opioid Use Disorder (Bridge Trial)

Phase 2 & 3
Recruiting
Led By Eric Strain
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of day 9
Awards & highlights

Bridge Trial Summary

This trial is designed to study the efficacy of the Bridge Device, a neuromodulator medical device, for the treatment of Opioid Use Disorder. The device was cleared by the FDA based on safety, but not efficacy. The trial will enroll persons with active OUD who will be randomly assigned to one of three conditions: active BD with placebo, sham BD with lofexidine, or sham BD and placebo. The study will monitor participants for withdrawal symptoms and tolerance after device removal.

Who is the study for?
This trial is for adults aged 18-65 with Opioid Use Disorder seeking treatment, who are in good health and not using opioid agonist treatments or have significant medical conditions like heart issues, liver or kidney impairment. Participants must test positive for opioids or show withdrawal symptoms but can't be pregnant, breastfeeding, or have certain psychiatric illnesses.Check my eligibility
What is being tested?
The study tests the Bridge Device (BD), a neuromodulator cleared by the FDA for OUD treatment. It compares three groups: one with active BD and placebo pills, another with a sham BD and lofexidine (a non-opioid medication to ease withdrawal), and a third group with both sham BD and placebo. The efficacy of these interventions during opioid withdrawal will be evaluated over several weeks.See study design
What are the potential side effects?
Possible side effects include skin irritation from the device, blood pressure changes due to lofexidine, potential allergic reactions to study medications, fatigue from naloxone-induced withdrawal challenges during the trial period.

Bridge Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Bridge Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of day 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of day 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Withdrawal Severity as measured by COWS peak daily score
Withdrawal Severity as measured by Clinical Opiate Withdrawal Scale (COWS) peak score
Withdrawal Severity as measured by area under the curve COWS score
Secondary outcome measures
Number of concomitant medications used
Proportion of Participants who initiate naltrexone at the end of the study
Proportion of participants retained
+3 more

Side effects data

From 2021 Phase 4 trial • 6 Patients • NCT04126083
17%
Orthostatic Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lofexidine

Bridge Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active Bridge Device/ Placebo Study DrugExperimental Treatment2 Interventions
Active Bridge Device and placebo study drug
Group II: Lofexidine/Sham Bridge DeviceActive Control2 Interventions
Lofexidine (Lucemyra) encapsulated
Group III: Sham Bridge Device /Placebo Study DrugPlacebo Group2 Interventions
Inactive Bridge Device and placebo study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,269 Previous Clinical Trials
14,838,567 Total Patients Enrolled
1 Trials studying Opioid Addiction
106 Patients Enrolled for Opioid Addiction
National Institute on Drug Abuse (NIDA)NIH
2,472 Previous Clinical Trials
2,619,547 Total Patients Enrolled
4 Trials studying Opioid Addiction
573 Patients Enrolled for Opioid Addiction
Eric StrainPrincipal InvestigatorJohns Hopkins University

Media Library

Bridge Device (Neuromodulator Medical Device) Clinical Trial Eligibility Overview. Trial Name: NCT04325659 — Phase 2 & 3
Opioid Addiction Research Study Groups: Sham Bridge Device /Placebo Study Drug, Active Bridge Device/ Placebo Study Drug, Lofexidine/Sham Bridge Device
Opioid Addiction Clinical Trial 2023: Bridge Device Highlights & Side Effects. Trial Name: NCT04325659 — Phase 2 & 3
Bridge Device (Neuromodulator Medical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04325659 — Phase 2 & 3

Frequently Asked Questions

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

What are the intended benefits of this clinical trial?

"This trial will evaluate the efficacy of a new medication for treating opioid withdrawal symptoms. The primary outcome measure will be the withdrawal severity as measured by the Clinical Opiate Withdrawal Scale (COWS) peak daily score. Secondary outcomes include the withdrawal severity as measured by the area under the curve Subjective Opiate Withdrawal Scale (SOWS) score, the proportion of participants retained during the 9 day intervention, and the withdrawal severity as measured by the Subjective Opiate Withdrawal Scale (SOWS) peak score."

Answered by AI

Can adults participate in this research project?

"The requirements to participate in this trial state that applicants must be between 18-65 years old. Out of the 277 total studies, 22 are for patients under 18 and 255 are for patients over 65."

Answered by AI

Are new people being accepted into this clinical trial currently?

"That is accurate. The clinical trial, which was initially posted on November 15th 2020, is still recruiting patients. The trial seeks 75 individuals from 1 location."

Answered by AI

What is the historical research involving the Bridge Device?

"Currently, 5 studies are ongoing that involve the Bridge Device. 1 of those is a Phase 3 study. The majority of the research is taking place in Baltimore, although there are 7 total sites."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
District of Columbia
Arizona
Other
How old are they?
18 - 65
What site did they apply to?
Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have tried to obtain from opiates but I cannot withstand the withdrawal symptoms. I have attempted the busbar study in Baltimore last year, unsuccessfully. At that time this study was on hold so I was accepted into that study. I really want to be off opiates, it controls every aspect of my life, I cannot plan for anything without first making sure I have what I need to be well from opiates and I hate that part of my life. This is something I have not tried and maybe that's what I need to get on with my life .
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
An Innovative Intervention for OUD Treatment
2020. "An Innovative Intervention for OUD Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04325659.
All > Opioid Dependence
~22 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top