drugset / Trial / NCT06877858
MethaLoad Dose-Finding Study
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2025-09-25
- Primary completion
- 2027-03
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methadone | Other / unclassified | 40 mg | Oral |
| Subject | Methadone | Other / unclassified | 60 mg | Oral |
| Subject | Methadone | Other / unclassified | 80 mg | Oral |
| Subject | Methadone | Other / unclassified | 100 mg | Oral |
| Subject | Methadone | Other / unclassified | 120 mg | Oral |