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NCT06877858 · ClinicalTrials.gov registry record · Phase 1
MethaLoad Dose-Finding Study
A Phase 1 study of Opioid Use Disorder (OUD), sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06877858: Recruiting Phase 1 study of Opioid Use Disorder (OUD), sponsored by University of Pennsylvania.
NCT06877858 is a Phase 1 study of Opioid Use Disorder (OUD) that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 24 participants, below the 314-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06877858, a Phase 1 study of Opioid Use Disorder (OUD), is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Methadone hydrochloride
Study Locations (1)
Pennsylvania
- Penn Center for Studies of Addiction (CSA) - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-09-25 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06877858 shows while recruiting
NCT06877858 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 314-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Opioid Use Disorder (OUD) appearing as the primary indexed condition, and to 1 intervention - of which Methadone hydrochloride is the first listed.
NCT06877858 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06877858 about?
NCT06877858 is a clinical study titled "MethaLoad Dose-Finding Study". 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 re...
What is the current status of trial NCT06877858?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-09-25. Estimated completion is 2027-07.
What conditions does trial NCT06877858 study?
This clinical trial studies the following conditions: Opioid Use Disorder (OUD).
What interventions are being tested in trial NCT06877858?
The interventions under investigation include: Methadone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06877858?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06877858 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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