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New treatment option for Opioid Use Disorder
Official title Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
ClinicalTrials.gov ID: NCT06538558
What this study is testing
What is Tezampanel?
Tezampanel is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for opioid use disorder.
Also referred to as TZP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Already engaged and fully assessed in a longitudinal-outpatient treatment program that provides opioid addiction treatment encompassing the full...
You likely can't join if
- 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...
- 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...
- 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...
- Seizure disorder; use of anti-convulsant for bipolar disorder, seizure, or chronic pain (including topiramate, gabapentin, carbamazepine, valproic...
See the full eligibility criteria
- 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®)...
- maintenance treatment (methadone or buprenorphine treatment) for study non-completers, or
- 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...
- 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.
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.