What side effects are associated with this type of intervention?

Common treatments for opioid addiction, such as neuromodulation and pharmacologic therapies, have various side effects. Neuromodulation devices like the Bridge Device may cause discomfort at the application site, headaches, and dizziness. Pharmacologic treatments like lofexidine can lead to hypotension, bradycardia, insomnia, and gastrointestinal issues, while naltrexone may cause nausea, headache, and liver enzyme abnormalities. Combining these treatments could result in compounded side effects.

What prior FDA approvals exist?

The FDA has cleared the Bridge Device, a neuromodulation medical device, for the treatment of Opioid Use Disorder (OUD). Unlike traditional pharmacological treatments, the Bridge Device did not require efficacy demonstration before clearance. Traditional FDA-approved treatments for opioid addiction include medications like buprenorphine-naloxone, which is available in various formulations such as buccal soluble films. These treatments focus on reducing withdrawal symptoms and cravings, aiding in the recovery process.

What other types of research exist?

Promising alternatives to the Bridge Device for opioid addiction treatment include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in treating various substance use disorders; 2) Vagus Nerve Stimulation (VNS), which has been studied for treatment-resistant depression and may have applications in addiction; 3) Comprehensive Medication-Assisted Treatment (MAT) programs that combine medications like buprenorphine or naltrexone with behavioral therapies; and 4) Multimodal pain management strategies that reduce opioid use post-surgery or in chronic pain conditions, such as the use of dexmedetomidine or multimodal analgesia protocols.

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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

Must not have

Hepatic or renal impairment, as indicated by the following lab results at the screening session: Aspartate aminotransferase or alanine transaminase >3x upper limit of normal (ULN), Total Bilirubin >2x ULN, Creatinine >1.5x ULN

Treatment with a strong 2D6 inhibitor (e.g., paroxetine, thioridazine, cinacalcet, bupropion, methotrimeprazine, fluoxetine, midostaurin, propafenone, glycerol phenylbutyrate, halofantrine, cisapride, dacomitinib, orphenadrine, quinidine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of day 9

Summary

This trial is testing a device called the Bridge Device, which uses electrical signals to help people with opioid addiction. The study focuses on individuals who are not currently on any medication for their addiction. The device aims to ease withdrawal symptoms by sending signals to the brain. Participants will be monitored to see if the device effectively reduces withdrawal symptoms.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver or kidney function tests are higher than normal.

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I am not taking medications like paroxetine or fluoxetine.

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I use medical cannabis.

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I need medical help to stop using alcohol or benzodiazepines due to dependence.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of day 9

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Number of concomitant medications used

Proportion of Participants who initiate naltrexone at the end of the study

Proportion of participants retained

+3 more

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for opioid addiction include neuromodulation, buprenorphine, and naltrexone. Neuromodulation, such as the Bridge Device, aims to alleviate withdrawal symptoms by stimulating specific nerves, potentially reducing the discomfort associated with opioid withdrawal. Buprenorphine is a partial opioid agonist that binds to opioid receptors, reducing cravings and withdrawal symptoms without producing the same high as other opioids, thus lowering the risk of misuse. Naltrexone is an opioid antagonist that blocks opioid receptors, preventing the euphoric effects of opioids and helping to maintain abstinence. These treatments are crucial for opioid addiction patients as they address both the physical dependence and the psychological aspects of addiction, improving the chances of successful recovery.

Enhanced Recovery After Surgery Protocol for Primary Cleft Palate Repair: Improving Transition of Care.The effectiveness of opioid substitution treatments for patients with opioid dependence: a systematic review and multiple treatment comparison protocol.Opioid dependence: rationale for and efficacy of existing and new treatments.