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
Proniras Corporation
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.
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).
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male, female or non-binary, age 18 to 65 years of age at Screening. 2. Diagnosis of Opioid Use Disorder (OUD) 3. Positive Urine Drug Screen (UDS) for opioid(s) at the Screening and Baseline Visits. 4. Recent active/chronic use of short-acting illicit and/or prescribed opioids and/or long-acting Opioid Use Disorder (OUD) maintenance treatments buprenorphine or methadone at the Screening and Baseline Visits. 5. Already engaged and fully assessed in a longitudinal-outpatient treatment program that provides opioid addiction treatment encompassing the full spectrum of opioid…
Interventions
- DrugTezampanel
Study drug will be given intravenously (mg/kg) at 6 timepoints during study participation
- DrugPlacebo
Placebo will be given intravenously (mg/kg) at 6 timepoints during study participation to a subset of participants in each cohort.
Location
- Indiana University School of MedicineIndianapolis, Indiana