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.
Male, female or non-binary, age 18 to 65 years of age at Screening.
Diagnosis of Opioid Use Disorder (OUD)
Positive Urine Drug Screen (UDS) for opioid(s) at the Screening and Baseline Visits.
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.
Active psychosis or mania that is impairing insight, decision-making, perception, or ability to provide informed consent as assessed by the PI or designee during the Screening or Baseline Visits, discussion with the outpatient treatment provider, or at Study Day 1.
Active suicidal ideation or intent as assessed by the PI or designee during the Baseline Visit interview or the C-SSRS on Study Day 1.
Chronic benzodiazepine use, or at significant risk for, or in a state of benzodiazepine withdrawal at the Screening or Baseline Visits, Study Day 1, or in discussion with the outpatient treatment provider.
Alcohol Use Disorder as assessed by the PI or designee with > 14 drinks / week (average of > 2 / day) at the Screening or Baseline Visits or Study Day 1 or in discussion with the outpatient treatment provider.
Sequential
Tezampanel
DrugStudy drug will be given intravenously (mg/kg) at 6 timepoints during study participation
Placebo
DrugPlacebo will be given intravenously (mg/kg) at 6 timepoints during study participation to a subset of participants in each cohort.
To evaluate systemic tolerability and safety of intravenous tezampanel administration.
Monitoring incidence of dose-limiting toxicities, incidence and severity of treatment emergent adverse events.
To characterize Cmax (maximum concentration) of tezampanel
Samples will be collected and analyzed at various timepoints per protocol
To characterize Area Under the Curve (AUC) concentration of tezampanel
Samples will be collected and analyzed at various timepoints per protocol
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Proniras Corporation
Lead sponsor
Indiana University
Collaborator
