RecruitingPhase 1NCT06538558

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

Sponsor

Proniras Corporation

Enrollment

40 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Tezampanel for people with opioid-use disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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