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A Dose-Finding Study of Methadone Loading Dose Initiation for Opioid Use Disorder With Fentanyl Use
The goal of this study is to develop a loading dose approach to starting methadone to treat opioid use disorder with fentanyl use ("fentanyl OUD", herein). This study is a participant- and assessor- blinded dose-finding study using the Bayesian optimal interval (BOIN) design. Investigators aim to recruit n=24 participants with fentanyl OUD to a research unit for monitored methadone initiation. Participants will be randomized to standard initiation vs. loading dose initiation at one of four doses.
Details
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 24 |
| Start date | 2025-09-25 |
| Completion | 2027-07 |
Conditions
- Opioid Use Disorder (OUD)
Interventions
- Methadone hydrochloride
Primary outcomes
- Dose-limiting toxicity (DLT) rate — 24 hours
The primary objective of the study is to identify a methadone loading dose approach appropriate for future study as an alternative initiation strategy for individuals with OUD using fentanyl or other high-potency synthetic opioids. The loading dose appropriate for future study will be identified as the highest loading dose with a dose-limiting toxicity (DLT) rate less than 10%. DLT definition: the proportion of individuals in each loading dose arm who meet any one of four safety outcomes within 24 hours of methadone loading dose administration: (1) Richmond Agitation-Sedation Scale (RASS) less than -1, (2) respiratory rate (RR) less than 8 breaths per minute, (3) peripheral oxygen saturation (SpO2) less than 92%, or (4) corrected QT interval (QTc) greater than 500ms.
Countries
United States