Opioid Drug Interaction Study

NCT06757140 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 97946R01DA016718
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

inpatient study; opioids; opiates; sedatives; opioid misuse

Outcome Measures

Primary Outcomes (1)

• Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking

  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.

  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).

Secondary Outcomes (4)

• Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect

  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).

• Change in Respiration Rate

  Respiration rate recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

• Change in End-tidal Carbon Dioxide (EtCO2)

  End-tidal Carbon Dioxide (EtCO2) recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

• Change in Oxygen Saturation

  Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

Study Arms (9)

Placebo / Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Placebo / Oxycodone low oral dose (Percocet, Roxicodone)

EXPERIMENTAL

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).

Drug: Oxycodone; Drug: Placebo

Placebo / Oxycodone high oral dose (Percocet, Roxicodone)

EXPERIMENTAL

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).

Drug: Oxycodone; Drug: Placebo

Alprazolam low oral dose (Xanax) / Placebo

EXPERIMENTAL

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).

Drug: Alprazolam; Drug: Placebo

Alprazolam high oral dose (Xanax) / Placebo

EXPERIMENTAL

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).

Drug: Alprazolam; Drug: Placebo

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

EXPERIMENTAL

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).

Drug: Alprazolam; Drug: Oxycodone

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

EXPERIMENTAL

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).

Drug: Alprazolam; Drug: Oxycodone

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

EXPERIMENTAL

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).

Drug: Alprazolam; Drug: Oxycodone

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

EXPERIMENTAL

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).

Drug: Alprazolam; Drug: Oxycodone

Interventions

Alprazolam DRUG

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

Also known as: Xanax

Alprazolam high oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone); Alprazolam high oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone); Alprazolam high oral dose (Xanax) / Placebo; Alprazolam low oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone); Alprazolam low oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone); Alprazolam low oral dose (Xanax) / Placebo

Oxycodone DRUG

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

Also known as: Percocet, Roxicodone

Alprazolam high oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone); Alprazolam high oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone); Alprazolam low oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone); Alprazolam low oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone); Placebo / Oxycodone high oral dose (Percocet, Roxicodone); Placebo / Oxycodone low oral dose (Percocet, Roxicodone)

Placebo DRUG

Participants will receive inactive oral doses

Alprazolam high oral dose (Xanax) / Placebo; Alprazolam low oral dose (Xanax) / Placebo; Placebo / Oxycodone high oral dose (Percocet, Roxicodone); Placebo / Oxycodone low oral dose (Percocet, Roxicodone); Placebo / Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanna Babalonis, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40508, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Alprazolam; Oxycodone; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Shanna Babalonis, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul A Nuzzo

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)