Opioid Use DisorderPhase 1NCT06538558
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
A Phase 1 study testing Tezampanel in people with Opioid Use Disorder, run by Proniras Corporation at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Tezampanel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2024to 30 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Already engaged and fully assessed in a longitudinal-outpatient treatment program that provides opioid addiction treatment encompassing the full spectrum of opioid maintenance and abstinence (injectable Vivitrol®) treatments, in which the host clinic is prepared and equipped to continue with:
- maintenance treatment (methadone or buprenorphine treatment) for study non-completers, or
Show all 13Show fewer
- long-acting injectable naltrexone treatment (Vivitrol®), for completers with next dose delivered approximately 30 days after Study Day 6.
- Post-menopausal/sterile or agree to use chemical or barrier methods of birth control from time of informed consent through 30 days post last treatment.
- Stable concomitant medications.
- Stable concomitant medications for depression, post-traumatic stress disorder, psychotic disorders, and bipolar spectrum disorders if one of the following: SSRI, SNRI, bupropion, MAOI, trazodone, Tricyclic, typical and atypical antipsychotics, lithium, antihistamine, alpha-adrenergic agent, nicotine replacement.
- Stable concomitant medications: propranolol, prazosin, and clonidine if used for psychiatric reasons, and not to control hypertension at the Baseline Visit and unchanged on Study Day 1.
- Provide informed consent.
- Understand and follow Lifestyle Considerations per protocol.
Who cannot join
- Clinically at risk or unstable due to:
- 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.
- Seizure disorder; use of anti-convulsant for bipolar disorder, seizure, or chronic pain (including topiramate, gabapentin, carbamazepine, valproic acid) at the Screening or Baseline Visits or Study Day 1.
Show all 22Show fewer
- Cardiac abnormalities including arrythmia, conduction abnormality or baseline QTC prolongation (QTcF > 450 males; 470 females); pacemaker, history of myocardial infarction at the Baseline Visit.
- Hypertension, diabetes mellitus, cancer, liver, and/or kidney disease and associated medications at the Screening or Baseline Visits or at Study Day 1.
- Abnormal safety laboratory results.
- ALT or AST > 3xs upper limit of normal at Baseline or Study Day 1.
- Undiagnosed hypertension defined as:
- Baseline Visit: BP > 160 / 100 mmHg or heart rate > 120 bpm
- Study Day 1: BP ≥ 180 / 120 mmHg or heart rate ≥ 140 bpm that continues after 10 minutes of rest.
- Temperature > 38.1°C at the Baseline Visit. Temperature > 38.9°C at the Study Day 1.
- Medications that stimulate the dopamine system pre- or post-synaptically, including L-Dopa, lisdexamfetamine, modafinil, gabapentin, phenobarbital, etc.) at the Screening or Baseline Visits or Study Day 1.
- Medications for addiction, ADHD, insomnia, or bipolar spectrum disorders involving dopamine system stimulants, benzodiazepines, barbiturates, or mood stabilizers active via GABA or glutamate receptor system (e.g. valproic acid, lamotrigine, carbamazepine, acamprosate, disulfiram) at the Screening or Baseline Visits or Study Day 1.
- Use of naltrexone or acamprosate (active at opioid or glutamatergic receptors) at the Screening or Baseline Visits or Study Day 1.
- Significant, active infection (e.g., positive for syphilis, tuberculosis, COVID-19, HBV) at the Baseline Visit.
- Symptomatic HIV or HCV (detectable viral load) at the Baseline Visit.
- Pregnancy or breastfeeding at the Screening or Baseline Visits or Study Day 1.
- Poor venous access at the Baseline Visit or Study Day 1.
- Participation in a research study involving another investigational drug in the last 3 months at the Screening Visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
R. Andrew Chambers, M.D., 317-775-7988, indytzp@iu.edu
About this study
Official title: A Phase I, Single-Center, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Efficacy of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
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.
Read the detailed description
This study is a phase I, single-center, single-blind, dose escalation study conducted in four cohorts to characterize the safety, tolerability, PK profile and efficacy of TZP for mitigation of OWS in treatment-seeking participants. Participants must be established in an outpatient treatment program and may be taking either long-acting opioid maintenance medications, methadone/buprenorphine, or short-acting opioids (not yet converted to a long-acting maintenance medication).
- Conditions
- Opioid Use Disorder
- Being tested
- Tezampanel, Placebo
- Keywords
- opioid, OUD, opioid withdrawal syndrome
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezampanelDrug
Also called TZP
Study drug will be given intravenously (mg/kg) at 6 timepoints during study participation
PlaceboDrug
Also called PBO
Placebo will be given intravenously (mg/kg) at 6 timepoints during study participation to a subset of participants in each cohort.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | 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. Receives: Drug: Tezampanel; Drug: Placebo |
| Cohort B | Experimental | 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. Receives: Drug: Tezampanel; Drug: Placebo |
| Cohort C | Experimental | 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. Receives: Drug: Tezampanel; Drug: Placebo |
| Cohort D | Experimental | 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. Receives: Drug: Tezampanel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate systemic tolerability and safety of intravenous tezampanel administration.
Monitoring incidence of dose-limiting toxicities, incidence and severity of treatment emergent adverse events.
Measured: First Dose through Day 10 visit
Secondary outcomes (2)
To characterize Cmax (maximum concentration) of tezampanel
Samples will be collected and analyzed at various timepoints per protocol
Measured: Day 2 and Day 5 (multiple pre and post dose timepoints)
To characterize Area Under the Curve (AUC) concentration of tezampanel
Samples will be collected and analyzed at various timepoints per protocol
Measured: Day 2 and Day 5 (multiple pre and post dose timepoints)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start16 Oct 2024
- Primary completion14 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants will be divided into four dose escalation cohorts. A DSMB safety review will be completed after each cohort (at a minimum) to determine appropriateness of continuing dose escalation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proniras Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538558
- Sponsor's protocol ID
- TZP-OWS-001
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Efficacy of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06538558
- Acronym / sponsor ID
- TZP-OWS-001
- Conditions
- Opioid Use Disorder
- Keywords
- opioid, OUD, opioid withdrawal syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Proniras CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a phase I, single-center, single-blind, dose escalation study conducted in four cohorts to characterize the safety, tolerability, PK profile and efficacy of TZP for mitigation of OWS in treatment-seeking participants. Participants must be established in an outpatient treatment program and may be taking either long-acting opioid maintenance medications, methadone/buprenorphine, or short-acting opioids (not yet converted to a long-acting maintenance medication).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants will be divided into four dose escalation cohorts. A DSMB safety review will be completed after each cohort (at a minimum) to determine appropriateness of continuing dose escalation.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Tezampanel, Drug: Placebo10 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. |
| Cohort B | Experimental | Drug: Tezampanel, Drug: Placebo10 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. |
| Cohort C | Experimental | Drug: Tezampanel, Drug: Placebo10 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. |
| Cohort D | Experimental | Drug: Tezampanel, Drug: Placebo10 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Already engaged and fully assessed in a longitudinal-outpatient treatment program that provides opioid addiction treatment encompassing the full spectrum of opioid maintenance and abstinence (injectable Vivitrol®) treatments, in which the host clinic is prepared and equipped to continue with:
Key exclusion criteria (22 listed)
- Clinically at risk or unstable due to:
- Abnormal safety laboratory results.
- ALT or AST > 3xs upper limit of normal at Baseline or Study Day 1.
- Undiagnosed hypertension defined as:
- Temperature > 38.1°C at the Baseline Visit. Temperature > 38.9°C at the Study Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezampanelAlso: TZPStudy drug will be given intravenously (mg/kg) at 6 timepoints during study participation | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
| PlaceboAlso: PBOPlacebo will be given intravenously (mg/kg) at 6 timepoints during study participation to a subset of participants in each cohort. | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
Primary outcome
To evaluate systemic tolerability and safety of intravenous tezampanel administration.
Time frame: First Dose through Day 10 visit
Monitoring incidence of dose-limiting toxicities, incidence and severity of treatment emergent adverse events.
2 secondary outcomes
To characterize Cmax (maximum concentration) of tezampanel
Time frame: Day 2 and Day 5 (multiple pre and post dose timepoints)
To characterize Area Under the Curve (AUC) concentration of tezampanel
Time frame: Day 2 and Day 5 (multiple pre and post dose timepoints)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tezampanel in people with Opioid Use Disorder, run by Proniras Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Toombs (206-957-7321, ctoombs@proniras.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate systemic tolerability and safety of intravenous tezampanel administration. (time frame: First Dose through Day 10 visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.