NCT06877858

MethaLoad Dose-Finding Study

A Dose-Finding Study of Methadone Loading Dose Initiation for Opioid Use Disorder With Fentanyl Use

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Opioid Use Disorder (OUD)

Interventions

Type	Name	Description
DRUG	Methadone hydrochloride	Methadone loading dose initiation (vs. standard initiation in the TAU arm)

Timeline

• Start date: 2025-09-25
• Primary completion: 2027-03-01
• Completion: 2027-07-01
• First posted: 2025-03-14
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study