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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male, female, transgender, or non-binary, aged 18 years or older

• DSM-5 criteria for opioid use disorder, moderate-severe

• Fentanyl positive urine drug test

• Able to provide a dated \& written informed consent in English prior to the conduct of any study related procedures

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Ability to take oral medication and be willing to adhere to the dosage regimen

• Interest in starting methadone treatment for opioid use disorder at one of three locations: Merakey Parkside at 5000 Parkside, Merakey 5429 Germantown Avenue, or Merakey 1745 North 4th Street

• Reliable access to a working phone

Locations
United States
Pennsylvania
Penn Center for Studies of Addiction (CSA)
RECRUITING
Philadelphia
Contact Information
Primary
Ashish P Thakrar, MD, MS
apthakrar@pennmedicine.upenn.edu
(215) 662-2250
Backup
Kyle Kampman, MD
kampman@pennmedicine.upenn.edu
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2027-07
Participants
Target number of participants: 24
Treatments
Active_comparator: Treatment as usual (TAU)
Day 1: 40mg oral methadone Day 2: 40mg oral methadone
Experimental: Loading Dose
Day 1: loading dose (60mg, 80mg, 100mg, or 120mg oral methadone) Day 2: 50% of the loading dose (30mg, 40mg, 50, or 60mg oral methadone)
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov