NCT05425420

Single Dose IV Methadone for Post-Op Pain

Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers (MTH02)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Kanecia Obie Zimmerman · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults.

Detailed description

The Adult Methadone study will be conducted at a single site, Duke Early Phase Research Unity (DEPRU), to enroll 24 participants. Participants will be treated/monitored overnight with Methadone hydrochloride IV (FDA approved and commercially available), with daily follow-up visits for 1 week total. The study aims to provide information on the disposition and clinical effects of intravenous methadone to update the drug label.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	methadone hydrochloride 0.1mg/kg	Single dose of methadone hydrochloride administered via intravenous (IV)

Timeline

• Start date: 2023-08-11
• Primary completion: 2024-01-20
• Completion: 2024-01-20
• First posted: 2022-06-21
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study