Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Opioid Use Disorder, sponsored by Proniras Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Monitoring incidence of dose-limiting toxicities, incidence and severity of treatment emergent adverse events.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tezampanel
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-10-16 |
| Est. Completion | 2025-11-30 |
| Phase | Phase 1 |
What NCT06538558 shows while recruiting
NCT06538558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06538558's enrollment target sits among peer trials
40 183rd of 257 higher than 67 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Right Tools, Right Time, Right Place: Telehealth for Opioid Use Disorder in Vulnerable Settings
RECRUITING · Phase 1
-
Cannabis and Opioid Use Disorder
RECRUITING · Phase 1
-
Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
RECRUITING · Phase 1
-
A Bundled Intervention
RECRUITING · Phase 1
-
Evaluation of the Interactions of Cannabidiol (CBD) With Morphine
RECRUITING · Phase 1
-
Exploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI