Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06877858

MethaLoad Dose-Finding Study

Led by University of Pennsylvania · Updated on 2025-10-14

24

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

MethaLoad Dose-Finding Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male, female, transgender, or non-binary, aged 18 years or older
  • Moderate to severe opioid use disorder diagnosed by DSM-5 criteria
  • Positive urine drug test for fentanyl
  • Able to give dated and written informed consent in English before any study procedures
  • Willing to follow all study procedures and available for the entire study duration
  • Able to take oral medication and willing to follow the dosing schedule
  • Interested in starting methadone treatment at one of three specified locations
  • Reliable access to a working phone
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to methadone
  • Pregnant or actively breastfeeding (confirmed by urine pregnancy test before screening and randomization)
  • Currently taking medications for opioid use disorder such as buprenorphine or methadone
  • At risk of benzodiazepine or alcohol withdrawal, including recent withdrawal or daily use
  • At risk of severe medetomidine withdrawal or recent ICU admission for withdrawal
  • At risk for methadone-induced heart rhythm problems as defined by ECG or medical history
  • Significant liver dysfunction (high AST/ALT or bilirubin levels)
  • Significant kidney dysfunction (eGFR ≤ 60 mL/min)
  • Chronic or symptomatic low blood pressure
  • Significant lung disease including low oxygen levels or COPD with notable breathlessness
  • Suspected gastrointestinal blockage
  • Active use of certain medications that affect methadone metabolism
  • Pending legal issues that could affect participation
  • Other psychiatric or medical conditions that might interfere with study completion or safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Penn Center for Studies of Addiction (CSA)

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

A

Ashish P Thakrar, MD, MS

CONTACT

K

Kyle Kampman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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MethaLoad Dose-Finding Study | DecenTrialz