Opioid Drug Interaction Study

Launched by SHANNA BABALONIS, PHD · Jan 1, 2025

Keywords

ClinConnect Summary

The Opioid Drug Interaction Study is a clinical trial designed to understand how different doses of opioid medications and alprazolam (a sedative) work on their own and together. The researchers want to find out how these drugs affect people in terms of how much they like the drugs, any feelings of being high, and physical responses, as well as how the body processes these medications through blood samples. This is an important study to ensure safe and effective use of these drugs, especially when they are taken together.

To participate in this study, you need to be between 18 and 55 years old, able to read and understand English, and have a body mass index (BMI) between 17 and 30. You'll also need to have some experience with opioid and sedative medications but should be generally healthy without any major medical or psychiatric conditions. If you join, you'll go through various tests and assessments to check your health and how your body reacts to the medications. It's important to know that the study is currently looking for participants, and you'll need to be willing to follow all study requirements, including giving blood samples for testing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • English-speaking and literate participants, able to understand and sign Informed Consent Document
• • ages 18 to 55 years old inclusive
• • BMI of greater than/equal to 17 and approximately less than or equal to 30
• • self-reported opioid use
• • self-reported sedative-like drug use
• • women of childbearing potential must not be pregnant or breastfeeding at screening and be using an effective form of contraception throughout study participation
• • otherwise healthy as determined by the medical/research team based on medical history, physical examination, vital signs, laboratory chemistries (blood chemistry with liver function tests and hematology, urinalysis and microscopic evaluation, 12-lead electrocardiogram)
• • willing and able to comply with all testing requirements defined in the protocol
• • adequate venous access (determined by RN) for pharmacokinetic blood draws
• Exclusion Criteria:
• • physical dependence on alcohol, opioids, benzodiazepines or sedative/hypnotics requiring medical management/detoxification
• • seeking treatment for opioid or any other drug use
• • acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders \[e.g., asthma, COPD\])
• • clinically significant abnormal ECG (as determined by study physician/cardiologist)
• • clinically significant abnormal laboratory findings (e.g., liver function tests greater than 3x the upper limits of normal range)
• • current or past history of major psychiatric disorder that would limit ability to participate in the study (e.g., bipolar disorder).
• • recent use of CYP2C9, CYP2D6 and CYP3A4 inhibitor or inducer that is long-acting and not amenable to a wash-out period after enrollment
• • known hypersensitivity to any of the study drugs
• • currently pregnant or breastfeeding
• • currently under parole or probation with urine testing requirements