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Opioid Drug Interaction Study

NCT06757140 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

DRUG

Alprazolam

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

DRUG

Oxycodone

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

DRUG

Placebo

Participants will receive inactive oral doses

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Shanna Babalonis, PhD

    lead OTHER

Principal Investigators

  • Shanna Babalonis, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2029-01-01
Completion
2029-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06757140 on ClinicalTrials.gov