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NCT06757140

Opioid Drug Interaction Study

Recruiting
PHASE1Ages 18–55InterventionalBasic science
Shanna Babalonis, PhD
~25 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:AlprazolamOxycodonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
Measured over This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

Conditions

Drug Interactions
Drug Kinetics

Explore related trials

Opioid Use DisorderSedative Use

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Shanna Babalonis, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Paul A Nuzzo
[email protected]
(859) 323-0002
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug LikingThis outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

    Participants rated their subjective drug liking on a standardized VAS scale (0 to 100) with higher scores equating to increased liking. Raw data transformed to peak scores.