Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 55Years
All Genders
NCT06757140

Opioid Drug Interaction Study

Led by Shanna Babalonis, PhD · Updated on 2026-05-14

25

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

S

Shanna Babalonis, PhD

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Opioid Drug Interaction Study

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking and literate participants, able to understand and sign Informed Consent Document
  • Ages 18 to 55 years old inclusive
  • Body mass index (BMI) of 17 or higher and approximately 30 or lower
  • Self-reported opioid use
  • Self-reported sedative-like drug use
  • Women of childbearing potential must not be pregnant or breastfeeding at screening and must use effective contraception throughout the study
  • Otherwise healthy based on medical history, physical exam, vital signs, lab tests, and ECG
  • Willing and able to comply with all study testing requirements
  • Adequate venous access for blood draws as determined by a nurse
Not Eligible

You will not qualify if you...

  • Physical dependence on alcohol, opioids, benzodiazepines, or sedative/hypnotics requiring medical management or detoxification
  • Seeking treatment for opioid or any other drug use
  • Acute medical problems requiring daily medication or ongoing care (e.g., infection, hypertension, cardiovascular disease, diabetes, respiratory disorders like asthma or COPD)
  • Clinically significant abnormal ECG
  • Clinically significant abnormal laboratory findings, such as liver function tests over three times normal
  • Current or past major psychiatric disorder limiting study participation (e.g., bipolar disorder)
  • Recent use of long-acting CYP2C9, CYP2D6, or CYP3A4 inhibitors or inducers not amenable to washout
  • Known allergy or hypersensitivity to study drugs
  • Currently pregnant or breastfeeding
  • Under parole or probation with urine testing requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Kentucky

Lexington, Kentucky, United States, 40508

Actively Recruiting

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Research Team

P

Paul A Nuzzo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

BASIC_SCIENCE

Number of Arms

9

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