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NCT06538558 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Opioid Use Disorder, sponsored by Proniras Corporation.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
1
Study location

NCT06538558 is a Phase 1 study of Opioid Use Disorder that is actively recruiting participants, run by Proniras Corporation. The registered enrollment target is 40 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06538558, a Phase 1 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Proniras Corporation.

RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Opioid Use Disorder

Interventions

  • DRUG Placebo
  • DRUG Tezampanel

Study Locations (1)

Indiana

  • Indiana University School of Medicine - Indianapolis

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2024-10-16
Est. Completion 2025-11-30
Phase Phase 1

Sponsor

Proniras Corporation

1 total trials

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What the Registry Record Tells You About NCT06538558

The ClinicalTrials.gov registry entry for NCT06538558 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The listed sponsor is Proniras Corporation, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06538558 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT06538558 about?

NCT06538558 is a clinical study titled "Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder". 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, pharmacok...

What is the current status of trial NCT06538558?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-10-16. Estimated completion is 2025-11-30.

What conditions does trial NCT06538558 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT06538558?

The interventions under investigation include: Placebo (DRUG), Tezampanel (DRUG).

Who is sponsoring clinical trial NCT06538558?

This trial is sponsored by Proniras Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06538558 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.