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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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.