A Dose-Finding Study of Methadone Loading Dose Initiation for Opioid Use Disorder With Fentanyl Use
University of Pennsylvania
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Male, female, transgender, or non-binary, aged 18 years or older 2. DSM-5 criteria for opioid use disorder, moderate-severe 3. Fentanyl positive urine drug test 4. Able to provide a dated \& written informed consent in English prior to the conduct of any study related procedures 5. Stated willingness to comply with all study procedures and availability for the duration of the study 6. Ability to take oral medication and be willing to adhere to the dosage regimen 7. Interest in starting methadone treatment for opioid use disorder at one of three locations: Merakey Parksi…
Interventions
- DrugMethadone hydrochloride
Methadone loading dose initiation (vs. standard initiation in the TAU arm)
Location
- Penn Center for Studies of Addiction (CSA)Philadelphia, Pennsylvania