Innovative treatment for opioid use disorder
Evaluating a Neuromodulator Medical Device (Bridge Device) for Opioid Use Disorder Treatment
This study is testing a new device to see if it can help people with opioid use disorder feel better during withdrawal compared to standard treatments.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | dacomitinib |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04325659 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of the Bridge Device, a neuromodulator medical device cleared by the FDA for treating Opioid Use Disorder (OUD). Participants with active OUD will be admitted to a Clinical Research Unit for a 2-3 week period, where they will undergo stabilization with morphine while receiving treatment with the Bridge Device, Lofexidine, or a placebo. The study aims to rigorously assess how effectively the device can alleviate opioid withdrawal symptoms compared to standard treatments. The trial includes both Phase 2 and Phase 3 evaluations to ensure comprehensive data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who meet the criteria for moderate or severe Opioid Use Disorder and are seeking treatment to stop using illicit opioids.
Not a fit: Patients who are currently receiving opioid agonist treatment or have significant psychiatric or medical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel and effective treatment option for individuals struggling with opioid dependence.
How similar studies have performed: While the Bridge Device has been cleared by the FDA, there is limited research specifically addressing its efficacy in treating opioid withdrawal, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 65 years old * Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe) based upon Mini-International Neuropsychiatric Interview (MINI) * Provides a urine sample that tests positive for opioids during screening or have evidence of opioid withdrawal * Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests * No significant psychiatric illnesses besides OUD * Seeking treatment to stop using illicit opioids * Willing to comply with the study protocol * Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation Exclusion Criteria: * Pregnant or breast feeding * Receiving opioid agonist treatment * Significant medical illness (e.g., insulin dependent diabetes) * Significant psychiatric illness (e.g., schizophrenia) * Use of medical cannabis * Contraindications for use of the Bridge Device, morphine, lofexidine or naloxone (e.g., hemophilia, psoriasis and other skin conditions, a cardiac pacemaker) * Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification * Hypotension (diastolic blood pressure of less than 60 mm Hg or systolic blood pressure of less than 90 mm Hg on screening examination) * Prolonged corrected QT interval interval on screening ECG (defined as \>0.44 seconds for males and \>0.46 seconds for females) * 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) * Have a known allergy to any of the study medications * Have circumstances that would interfere with study participation (e.g., impending jail)
Where this trial is running
Baltimore, Maryland
- Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Eric Strain — Johns Hopkins University
- Study coordinator: Cecilia L Bergeria, PhD
- Email: cberge21@jhmi.edu
- Phone: 410-550-1979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.