Opioid Drug Interaction Study
Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects
Shanna Babalonis, PhD
25 participants
Apr 1, 2025
INTERVENTIONAL
Summary
This study will examine the effects of doses of opioid/placebo and doses of alprazolam/placebo, alone and in combination. The primary outcomes are pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) and pharmacokinetic outcomes (from blood samples) to determine the interaction effects of these compounds.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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
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Interventions
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
Participants will receive inactive oral doses
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06757140