Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT04325659
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04325659
Study Brief:
Protocol Section:
NCT04325659