MethaLoad Dose-Finding Study
ConditionOpioid Use Disorder (OUD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Hypersensitivity or allergy to methadone that is previously documented
Pregnancy or actively lactating (with urine pregnancy test performed on screening and repeated on admission to the unit prior to randomization)
Taking medications for opioid use disorder, per self-report or per urine drug testing detection of buprenorphine or methadone
At risk of benzodiazepine or alcohol withdrawal as defined by: prior benzodiazepine or alcohol withdrawal in the past 3 months, current daily use of benzodiazepines or alcohol, or DSM-5 criteria for hypnotic-sedative or alcohol use disorder
Trial design
Treatments tested in this trial
- Methadone hydrochloride
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov