Opioid Drug Interaction Study

May 13, 2026 updated by: Shanna Babalonis, PhD

Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Alprazolam (Xanax®) is a short-acting benzodiazepine that is the commonly prescribed in the U.S. (>15 million prescriptions in 2021) and CDC reporting indicates that alprazolam was associated with the greatest increase in number of ED presentations of the benzodiazepines. This study will examine the effects of a widely prescribed and abused mu opioid agonist, oxycodone, and a widely prescribed and abused benzodiazepine, alprazolam, when given alone and in combination to experienced drug using volunteers. Key safety outcomes, including expired CO2, pharmacodynamic measures related to abuse potential, and cognitive/psychomotor performance will be thoroughly examined over a range of doses for both drugs alone and in combination. Pharmacokinetic data will also be collected and analyzed to assess the potential pharmacokinetic interaction as an underlying mechanism of action.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • University of Kentucky
        • Contact:
        • Principal Investigator:
          • Shanna Babalonis, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Drug: Placebo
Participants will receive inactive oral doses
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).
Drug: Placebo
Participants will receive inactive oral doses
Drug: Oxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
Other Names:
  • Roxicodone
  • Percocet
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).
Drug: Placebo
Participants will receive inactive oral doses
Drug: Oxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
Other Names:
  • Roxicodone
  • Percocet
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).
Drug: Placebo
Participants will receive inactive oral doses
Drug: Alprazolam
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
Other Names:
  • Xanax
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).
Drug: Placebo
Participants will receive inactive oral doses
Drug: Alprazolam
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
Other Names:
  • Xanax
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).
Drug: Oxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
Other Names:
  • Roxicodone
  • Percocet
Drug: Alprazolam
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
Other Names:
  • Xanax
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).
Drug: Oxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
Other Names:
  • Roxicodone
  • Percocet
Drug: Alprazolam
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
Other Names:
  • Xanax
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).
Drug: Oxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
Other Names:
  • Roxicodone
  • Percocet
Drug: Alprazolam
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
Other Names:
  • Xanax
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).
Drug: Oxycodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
Other Names:
  • Roxicodone
  • Percocet
Drug: Alprazolam
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
Other Names:
  • Xanax

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect
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).
Participants rated their subjective drug effect on a standardized VAS scale (0 to 100) with higher scores equating to increased effect. 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).
Change in Respiration Rate
Time Frame: Respiration rate recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).
Respiration rate monitored throughout each session. Raw data transformed to trough scores.
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)
Time Frame: 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 End-tidal Carbon Dioxide (EtCO2) monitored throughout each session. Raw data transformed to peak scores.
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
Time Frame: Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).
Oxygen Saturation monitored throughout each session. Raw data transformed to trough scores.
Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanna Babalonis, PhD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shanna Babalonis, PhD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 97946
  • R01DA016718 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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