Examining interactions between opioids and benzodiazepines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of oxycodone and alprazolam, both alone and in combination, on experienced drug users. It focuses on pharmacodynamic measures, such as subjective ratings of drug effects and physiological outcomes, as well as pharmacokinetic outcomes from blood samples. The goal is to understand how these substances interact and their potential for abuse. Safety outcomes, including cognitive and psychomotor performance, will also be assessed across various doses.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Shanna Babalonis, PhD — University of Kentucky
• Study coordinator: Paul A Nuzzo
• Email: paul.nuzzo@uky.edu
• Phone: (859) 323-0002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.