Are you or someone you love receiving treatment for opioid addiction?
R Andrew Chambers, MD
Primary Investigator
Brief description of study
Are you interested in being opioid-free? Join our study!
Researchers at Indiana University School of Medicine are looking for volunteers to take part in a study to test an investigational drug called Tezampanel for opioid withdrawal. The term “investigational drug” means it is not approved by the Food and Drug Administration (FDA).
Participants must be willing to attend 3 outpatient visits and a 7-day inpatient stay at University Hospital in Indianapolis, IN.
Compensation will be provided.
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This study is looking at:
1) the safety of giving Tezampanel (TZP) to people,
2) how TZP is broken down by the body,
3) whether there is a difference in opioid withdrawal symptoms between people who receive TZP versus people who do not,
4) whether people complete the 7-day inpatient stay and
5) whether people get the injection of the opioid antagonist called, Vivitrol®.
Who can take part?
Individuals ages 18 - 65 with a diagnosis of opioid use disorder who are participating in outpatient services that provide medication treatments. Participants will be referred by their treating addiction provider.
Detailed description of study
What will happen during the study?
- If you are eligible and choose to participate, you will have a 7-day inpatient stay at the Clinical Research Center (CRC) at University Hospital in Indianapolis, IN.
- During opioid withdrawal and treatment, you will need to stay in inpatient so that you can be monitored closely by the study physician and staff.
- You may receive clonidine, promethazine, loperamide, and ibuprofen, depending on the severity of your opioid withdrawal symptoms.
- You will receive hydroxyzine nightly and Vivitrol® on Day 6.
- You will have an outpatient visit on Day 10.
- If you smoke tobacco products, a nicotine patch will be offered to you daily.
- If you choose not to participate or decide to withdraw from the study, you will continue treatment with your current outpatient treatment provider.
Incentive/compensation
- You will receive up to $1,000 in the form of a re-loadable ViSA debit card for completing all of the study requirements ($800 at the time of discharge from the 7-day inpatient stay and $200 after Study Day 10).
- Paid parking validation will also be provided at each study visit.
- The benefits of participating in this study are that you will be closely monitored and supported while going through opioid withdrawal, you will receive Vivitrol® on Day 6 (opioid chemical blocker) and if you finish the study, you will no longer be taking any opioid medicines.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Opioid use disorder, Opioid addiction, OUD
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Age: 18 years - 65 years
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Gender: All
Inclusion criteria:
- Diagnosed with Opioid Use Disorder (OUD)
- Are currently involved in an outpatient treatment program
- Are taking short-acting (e.g., oxycodone for pain) or long-acting opioids (methadone/buprenorphine)
- Willing to transition to an opioid-free medication (Vivitrol®)
Exclusion criteria:
- Active psychosis or mania
- Active suicidal ideation or intent
- Chronic benzodiazepine use, or at significant risk for, or in a state of benzodiazepine withdrawal
- Alcohol Use Disorder
- Seizure disorder; use of anti-convulsant for bipolar disorder, seizure, or chronic pain (including topiramate, gabapentin, carbamazepine, valproic acid)
- Cardiac abnormalities including arrythmia, pacemaker, history of myocardial infarction
- Hypertension, diabetes mellitus, cancer, liver, and/or kidney disease and associated medications
- Pregnant or breast-feeding
- Additional conditions as determined by study PI/study team that would disqualify participant
Find a site
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What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
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