Study of Tezampanel for Opioid Withdrawal Syndrome

This study is looking at how safe and effective an investigational drug called Tezampanel is for treating Opioid Withdrawal Syndrome (OWS) in people with Opioid Use Disorder (OUD). Participants will receive either Tezampanel or a placebo (an inactive substance) through an IV (into a vein) daily for six days during a seven-day stay at a research center. The main goal is to see how well people tolerate Tezampanel and if it's safe. You may be able to join if you are 18 to 65 years old, have an OUD diagnosis, and test positive for opioids. This study is currently recruiting 40 participants.

Study design
This is a Phase 1, single-center, single-blind study with 40 participants. It uses a dose escalation approach, meaning different groups will receive increasing doses of Tezampanel.
What's involved
You would stay at a research center for seven days and receive Tezampanel or placebo intravenously six times during that stay.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be measured from the first dose through a visit on Day 10.

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NCT06538558

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Proniras Corporation
~40 participants
Updated 2024-11-06 on ClinicalTrials.gov
What's tested:TezampanelPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate systemic tolerability and safety of intravenous tezampanel administration.
Measured over First Dose through Day 10 visit
Opioid Use Disorder
1 sites across 1 states
Indiana1

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  • To evaluate systemic tolerability and safety of intravenous tezampanel administration.First Dose through Day 10 visit

    Monitoring incidence of dose-limiting toxicities, incidence and severity of treatment emergent adverse events.