Recruiting
Phase 1
Phase 2

Opioid Interaction

Sponsor:

Shanna Babalonis, PhD

Code:

NCT06757140

Conditions

Drug Interactions

Drug Kinetics

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Alprazolam

Oxycodone

Placebo

Study Details

Brief 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.

Conditions

Drug Interactions

Drug Kinetics

Study ID

NCT06757140

Start date

Apr 1, 2025

Status verified date

May, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo / Placebo

Participants will receive 2 drug administrations, neither will be active. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

experimental: Placebo / Oxycodone low oral dose (Percocet, Roxicodone)

Participants will receive 2 drug administrations, one dose oral placebo and one low dose oral oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

experimental: Placebo / Oxycodone high oral dose (Percocet, Roxicodone)

Participants will receive 2 drug administrations, one dose oral placebo and one high dose oral oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

experimental: Alprazolam low oral dose (Xanax) / Placebo

Participants will receive 2 drug administrations, one dose oral placebo and one low dose oral alprazolam. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

experimental: Alprazolam high oral dose (Xanax) / Placebo

Participants will receive 2 drug administrations, one dose oral placebo and one high dose oral alprazolam. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

experimental: Alprazolam low oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)

Participants will receive 2 non-therapeutic oral drug administrations, one low dose alprazolam, and one low dose oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

experimental: Alprazolam high oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)

Participants will receive 2 non-therapeutic oral drug administrations, one high dose alprazolam, and one low dose oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

experimental: Alprazolam low oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)

Participants will receive 2 non-therapeutic oral drug administrations, one low dose alprazolam, and one high dose oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

experimental: Alprazolam high oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)

Participants will receive 2 non-therapeutic oral drug administrations, one high dose alprazolam, and one high dose oxycodone. The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for both alprazolam and oxycodone ≈ 1.5 hr).

Interventions

Alprazolam

Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone

Oxycodone

Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam

Placebo

Participants will receive inactive oral doses

Primary outcome measure

  • Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Paul A Nuzzo

(859) 323-0002paul.nuzzo@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40508

Contacts

Paul A Nuzzo

859-323-0002paul.nuzzo@uky.edu

Principal Investigator:

Shanna Babalonis, PhD

More Information

Sponsor

Shanna Babalonis, PhD

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • inpatient study
  • opioids
  • opiates
  • sedatives
  • opioid misuse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shanna Babalonis, PhD on 2026-05-14.