An Innovative Intervention for OUD Treatment

Launched by JOHNS HOPKINS UNIVERSITY · Mar 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying an innovative medical device called the Bridge Device (BD), which is designed to help people with Opioid Use Disorder (OUD). The goal is to see how effective the BD is in treating symptoms of opioid withdrawal and helping people stop using opioids. Participants in the trial will stay at a Clinical Research Unit for 2-3 weeks, where they will be monitored closely and receive treatment with morphine to stabilize their condition. After this stabilization, they will be randomly assigned to one of three groups to test the BD or other treatment options.

To be eligible for the trial, participants must be between 18 and 65 years old and diagnosed with moderate to severe OUD. They should also be in good health, not currently receiving treatment for opioid addiction, and willing to follow the study guidelines. Throughout their stay, participants will have access to support and resources to help them continue treatment after the study ends. This trial is currently recruiting, and it offers a structured environment for individuals seeking help with opioid dependence.

Gender

ALL

Eligibility 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)