MethaLoad Dose-Finding Study

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 10, 2025

Keywords

ClinConnect Summary

The MethaLoad Dose-Finding Study is a research trial aimed at finding the best way to start treatment with methadone for people dealing with fentanyl use disorder, which is a type of addiction to powerful opioids. In this study, 24 participants will be involved, and they will be split into different groups. Some will receive the usual starting dose of methadone, while others will receive a higher initial dose, known as a "loading dose." The main goal is to find out which loading dose is the highest that people can tolerate without serious side effects. This research is important because it could help improve the way we treat opioid addiction.

To be eligible for this study, participants must be at least 18 years old, in good overall health, and have a positive urine test for fentanyl. They need to be willing to follow the study guidelines and take oral medication as directed. However, certain individuals, such as those with specific heart conditions or who are pregnant, cannot participate. If someone joins the study, they can expect to be closely monitored while receiving methadone in a controlled environment. After the study, participants will be connected to a treatment program for ongoing support. This trial is not yet recruiting, but it represents an important step in understanding how to best help those struggling with opioid use disorder.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to provide a dated written informed consent in English prior to the conduct of any study related procedures
• • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
• • 3. Male, female, transgender, or non-binary aged 18 or older
• • 4. In good general health as evidenced by medical history.
• • 5. Fentanyl positive urine drug test
• • 6. Ability to take oral medication and be willing to adhere to the dosage regimen
• • 7. For females of reproductive potential: negative urine pregnancy test on screening and on admission
• • 8. DSM-5 criteria for opioid use disorder, moderate to severe
• • 9. Interest in starting methadone treatment for opioid use disorder at Merakey Parkside (our partner outpatient treatment program where we will send patients on discharge from the study)
• Exclusion Criteria:
• • 1. Previously documented hypersensitivity or allergy to methadone
• • 2. Prolonged QTc (=450ms in men, =460ms in women), previously documented long QT syndrome, history of QT prolongation, or history of ventricular arrhythmia (e.g., torsades de pointes)
• • 3. Pregnancy or lactation
• • 4. DSM-5 criteria for benzodiazepine or alcohol use disorder
• • 5. Urine drug testing at screening positive for buprenorphine and/or methadone
• • 6. AST and/or ALT 3x upper limit of normal or total bilirubin or equal to 1.5x upper limit of normal
• • 7. eGFR less than or equal to 60 mL/min
• • 8. Chronic hypotension (\<90/50 mmHg) or episodic symptomatic hypotension (history of active or recurrent orthostatic hypotension or syncope).
• • 9. Significant chronic pulmonary disease: COPD with modified MRC Dyspnea Scale \>=3 ("I stop for breath after walking about one city block") or requiring oxygen (chronically or at bedtime)
• • 10. Active, chronic use of the CYP3A4-inducers or -inhibitors rifampin, phenytoin, St John's wort, phenobarbital, carbamazepine, voriconazole, efavirenz, nelfinavir, nevirapine, ritonavir, and lopinavir+ritonavir, abacavir, or amprenavir
• • 11. Significant medical symptoms, psychiatric symptoms, or dementia that, in the opinion of the investigators, would preclude compliance with the protocol, cooperation in the study, obtaining informed consent, or ability to safely participant in the study
• • 12. Pending legal action that could prohibit participation and/or compliance in study procedures