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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06877858
The ClinicalTrials.gov registry entry for NCT06877858 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 314-participant average among 7 other Opioid Use Disorder (OUD) trials with a reported enrollment target (92% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Related
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