NCT06538558

Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder

A Phase I, Single-Center, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Efficacy of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Proniras Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is examining the use of Tezampanel (TZP) for treatment of Opioid Withdrawal Syndrome (OWS) in participants with Opioid Use Disorder (OUD). Participants will receive TZP or placebo (PBO) daily on Days 2 - 7 during a 7-day inpatient stay at the research center to determine safety, pharmacokinetic (PK) assessment, and efficacy of TZP for OWS.

Detailed description

This study is a phase I, single-center, single-blind, dose escalation study conducted in four cohorts to characterize the safety, tolerability, PK profile and efficacy of TZP for mitigation of OWS in treatment-seeking participants. Participants must be established in an outpatient treatment program and may be taking either long-acting opioid maintenance medications, methadone/buprenorphine, or short-acting opioids (not yet converted to a long-acting maintenance medication).

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Tezampanel	Study drug will be given intravenously (mg/kg) at 6 timepoints during study participation
DRUG	Placebo	Placebo will be given intravenously (mg/kg) at 6 timepoints during study participation to a subset of participants in each cohort.

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-10-14
• Completion: 2025-11-30
• First posted: 2024-08-05
• Last updated: 2024-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study