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Tezampanel for Drug Withdrawal

Phase 1

Recruiting

Research Sponsored by Proniras Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Male, female or non-binary, age 18 to 65 years of age at Screening.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2 and day 5 (multiple pre and post dose timepoints)

Summary

This trial is looking at whether Tezampanel (TZP) can help treat Opioid Withdrawal Syndrome (OWS) in people with Opioid Use Disorder (OUD). Participants

Who is the study for?

This trial is for adults aged 18-65 with Opioid Use Disorder who've recently used opioids. They must be willing to stay inpatient for a week, have stable mental health medication if needed, and agree to birth control or are post-menopausal/sterile. Those on opioid maintenance treatment may join but can't be seeking other specific treatments.

What is being tested?

The study tests Tezampanel (TZP) against a placebo to see if it helps with Opioid Withdrawal Syndrome during a 7-day hospital stay. Participants will get TZP or placebo daily from Day 2 to Day 7 while their safety and the drug's effects are monitored.

What are the potential side effects?

Possible side effects of Tezampanel aren't detailed here, but typically studies like this watch out for any new symptoms that could range from mild discomforts like headaches or nausea to more serious issues depending on how the body reacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

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I currently use opioids or am on treatments like buprenorphine or methadone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2 and day 5 (multiple pre and post dose timepoints)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2 and day 5 (multiple pre and post dose timepoints)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 and day 5 (multiple pre and post dose timepoints) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate systemic tolerability and safety of intravenous tezampanel administration.

Secondary study objectives

To characterize Area Under the Curve (AUC) concentration of tezampanel

To characterize Cmax (maximum concentration) of tezampanel

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort DExperimental Treatment2 Interventions

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.

Group II: Cohort CExperimental Treatment2 Interventions

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.

Group III: Cohort BExperimental Treatment2 Interventions

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.

Group IV: Cohort AExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met