drugset
drugset / Trial / NCT05693675

Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months

NCT05693675 ↗

Phase 2/3 Withdrawn The University of Texas Health Science Center, Houston
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.

Timeline

Start
2023-10-01
Primary completion
2024-07-01
Completion
2024-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Methadone Other / unclassified 5 mg Intravenous
Background Fentanyl Other / unclassified — —
Background Hydromorphone Other / unclassified — —

Indications

No indication recorded.