Drug InteractionsPhase 1/2NCT06757140

Opioid Drug Interaction Study

A Phase 1/2 study testing Alprazolam and Oxycodone in people with Drug Interactions and Drug Kinetics, run by Shanna Babalonis, PhD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Drug Interactions, Drug Kinetics
What is being tested?: Alprazolam and Oxycodone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2025to 1 Jun 2029
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

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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

Who cannot join

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).

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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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Paul A Nuzzo contact

(859) 323-0002

paul.nuzzo@uky.edu

United States1 site, 1 recruiting

University of Kentucky
Lexington, Kentucky, 40508
Paul A Nuzzo, 859-323-0002, paul.nuzzo@uky.edu
Shanna Babalonis, PhD
Recruiting

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About this study

Official title: Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects

Read the 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.

Conditions: Drug Interactions, Drug Kinetics
Being tested: Alprazolam, Oxycodone, Placebo
Keywords: inpatient study, opioids, opiates, sedatives, opioid misuse
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlprazolamDrug
Also called Xanax
Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone
OxycodoneDrug
Also called Percocet, Roxicodone
Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam
PlaceboDrug
Participants will receive inactive oral doses

Study groups in NCT06757140
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Alprazolam; Drug: Oxycodone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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 monitored throughout each session. Raw data transformed to trough scores.
Measured: 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)
Change in End-tidal Carbon Dioxide (EtCO2) monitored throughout each session. Raw data transformed to peak scores.
Measured: 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 monitored throughout each session. Raw data transformed to trough scores.
Measured: Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20251 Jun 2029

First posted3 Jan 2025
Study start1 Apr 2025
Primary completion1 Jan 2029 (estimated)
Study completion1 Jun 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug InteractionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 25 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06757140
Sponsor's protocol ID: 97946
Other IDs: R01DA016718
Status last verified: May 2026
First submitted: 9 Dec 2024
Last updated: 14 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Interested in taking part?

Paul A Nuzzo

(859) 323-0002

paul.nuzzo@uky.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects
ClinicalTrials.gov ID: NCT06757140
Acronym / sponsor ID: 97946
Conditions: Drug Interactions, Drug Kinetics
Keywords: inpatient study, opioids, opiates, sedatives, opioid misuse
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 25 participants (estimated)
Lead sponsor: Shanna Babalonis, PhDUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Apr 2025 (actual)
Primary completion: 1 Jan 2029 (estimated)
Study completion: 1 Jun 2029 (estimated)
First posted: 3 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Placebo / Placebo	Placebo comparator	Drug: PlaceboParticipants 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).
Placebo / Oxycodone low oral dose (Percocet, Roxicodone)	Experimental	Drug: Oxycodone, Drug: PlaceboParticipants 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).
Placebo / Oxycodone high oral dose (Percocet, Roxicodone)	Experimental	Drug: Oxycodone, Drug: PlaceboParticipants 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).
Alprazolam low oral dose (Xanax) / Placebo	Experimental	Drug: Alprazolam, Drug: PlaceboParticipants 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).
Alprazolam high oral dose (Xanax) / Placebo	Experimental	Drug: Alprazolam, Drug: PlaceboParticipants 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).
Alprazolam low oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)	Experimental	Drug: Alprazolam, Drug: OxycodoneParticipants 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).
Alprazolam high oral dose (Xanax) / Oxycodone low oral dose (Percocet, Roxicodone)	Experimental	Drug: Alprazolam, Drug: OxycodoneParticipants 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).
Alprazolam low oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)	Experimental	Drug: Alprazolam, Drug: OxycodoneParticipants 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).
Alprazolam high oral dose (Xanax) / Oxycodone high oral dose (Percocet, Roxicodone)	Experimental	Drug: Alprazolam, Drug: OxycodoneParticipants 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).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (10 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlprazolamAlso: XanaxParticipants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone	Drug	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
OxycodoneAlso: Percocet, RoxicodoneParticipants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam	Drug	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)
PlaceboParticipants will receive inactive oral doses	Drug	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

Primary outcome

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.

4 secondary outcomes

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).
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).
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 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).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Paul A Nuzzo contact

(859) 323-0002

paul.nuzzo@uky.edu

Shanna Babalonis, PhD principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Alprazolam and Oxycodone in people with Drug Interactions and Drug Kinetics, run by Shanna Babalonis, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul A Nuzzo ((859) 323-0002, paul.nuzzo@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06757140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.