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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Proniras Corporation
Study ID
NCT06538558
Phase
PHASE1
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tezampanel — DRUG
    Study drug will be given intravenously (mg/kg) at 6 timepoints during study participation
  • Placebo — DRUG
    Placebo will be given intravenously (mg/kg) at 6 timepoints during study participation to a subset of participants in each cohort.

Study Details

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.

Key Dates

Start date
Oct 16, 2024
Status verified
Nov 2024
Primary completion
Oct 14, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    10 participants will be recruited. The first two participants will receive placebo followed by eight participants who will receive active drug (tezampanel) at the lowest dose level.
  • Experimental: Cohort B
    10 participants will be recruited. The first two participants will receive placebo followed by eight participants who will receive active drug (tezampanel) at the next highest dose level.
  • Experimental: Cohort C
    10 participants will be recruited. The first two participants will receive placebo followed by eight participants who will receive active drug (tezampanel) at the next highest dose level.
  • Experimental: Cohort D
    10 participants will be recruited. The first two participants will receive placebo followed by eight participants who will receive active drug (tezampanel) at the next highest dose level.

Primary Outcome Measure

To evaluate systemic tolerability and safety of intravenous tezampanel administration. [ Time Frame: First Dose through Day 10 visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of MedicineIndianapolisIndiana46202
R. Andrew Chambers, M.D.
[email protected]
317-775-7988

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By research site
Indiana University School of Medicine· Indianapolis, IN

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