Actively Recruiting
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Led by Proniras Corporation · Updated on 2024-11-06
40
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
Sponsors
P
Proniras Corporation
Lead Sponsor
I
Indiana University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, or non-binary, age 18 to 65 years at Screening
- Diagnosis of Opioid Use Disorder (OUD)
- Positive Urine Drug Screen for opioids at Screening and Baseline Visits
- Recent active or chronic use of short-acting illicit or prescribed opioids or long-acting opioid maintenance treatments (buprenorphine or methadone) at Screening and Baseline
- Currently engaged and fully assessed in a longitudinal outpatient opioid addiction treatment program
- Able to continue maintenance treatment (methadone or buprenorphine) if not completing the study, or injectable naltrexone (Vivitrol) for completers
- Post-menopausal, sterile, or agree to use birth control from consent through 30 days after last treatment
- Stable use of concomitant medications
- Stable use of specific medications for depression, PTSD, psychotic disorders, and bipolar spectrum disorders as listed
- Stable use of propranolol, prazosin, or clonidine if for psychiatric reasons and unchanged at Baseline and Study Day 1
- Provide informed consent
- Understand and follow lifestyle considerations per protocol
You will not qualify if you...
- Active psychosis or mania impairing decision-making or consent ability
- Active suicidal thoughts or intent
- Chronic benzodiazepine use or withdrawal risk
- Alcohol Use Disorder with more than 14 drinks per week
- Seizure disorder or use of anticonvulsants for bipolar, seizure, or chronic pain
- Cardiac abnormalities including arrhythmia, conduction issues, QTc prolongation, pacemaker, or history of myocardial infarction
- Hypertension, diabetes, cancer, liver or kidney disease and related medications
- Abnormal safety laboratory results
- ALT or AST levels more than 3 times upper normal limit
- Undiagnosed hypertension with high blood pressure or heart rate at Baseline or Study Day 1
- Fever above 38.1°C at Baseline or above 38.9°C at Study Day 1
- Use of medications stimulating dopamine system or certain addiction/psychiatric medications at Baseline or Study Day 1
- Use of naltrexone or acamprosate at Baseline or Study Day 1
- Active infection like syphilis, tuberculosis, COVID-19, or hepatitis B
- Symptomatic HIV or hepatitis C with detectable viral load
- Pregnancy or breastfeeding
- Poor venous access
- Participation in another investigational drug study within last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
C
Christopher Toombs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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