Methadone Loading Dose Study for Opioid Use Disorder
This study is testing a new way to start methadone hydrochloride treatment for people with moderate to severe opioid use disorder (OUD) who are also using fentanyl. Researchers want to see if starting with a "loading dose" of methadone is better than the standard way of starting treatment. They will be looking at how safe the different starting doses are within the first 24 hours. You might be able to join if you are 18 or older, have moderate to severe OUD, and a fentanyl-positive urine test. The study plans to enroll 24 participants, but its current recruitment status is unclear.
- Study design
- This is a dose-finding study that will compare a methadone loading dose to standard initiation. It is blinded, meaning participants and assessors won't know which treatment is being given, and plans to enroll 24 participants.
- What's involved
- Participants will be randomized to either standard or loading dose initiation and will be monitored in a research unit. Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety measure is assessed at 24 hours. Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MethaLoad Dose-Finding Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Dose-limiting toxicity (DLT) rate24 hours
The primary objective of the study is to identify a methadone loading dose approach appropriate for future study as an alternative initiation strategy for individuals with OUD using fentanyl or other high-potency synthetic opioids. The loading dose appropriate for future study will be identified as the highest loading dose with a dose-limiting toxicity (DLT) rate less than 10%. DLT definition: the proportion of individuals in each loading dose arm who meet any one of four safety outcomes within 24 hours of methadone loading dose administration: (1) Richmond Agitation-Sedation Scale (RASS) less than -1, (2) respiratory rate (RR) less than 8 breaths per minute, (3) peripheral oxygen saturation (SpO2) less than 92%, or (4) corrected QT interval (QTc) greater than 500ms.