Status:
RECRUITING
An Innovative Intervention for OUD Treatment
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-Related Disorders
Opioid Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment. Importantly, medical devices reviewed by the FDA are cleared (based ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04325659
Start Date
November 15 2020
End Date
January 1 2026
Last Update
August 24 2025
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224