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Xanax and opioids: new study tests safety and abuse risk

NCT ID NCT06757140

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing how the drugs alprazolam (Xanax) and oxycodone (an opioid) interact when taken together. Researchers will give small, non-therapeutic doses to 25 healthy adults who already use these drugs. They will measure how much participants like the drug combination, any side effects, and how the drugs move through the body. The goal is to better understand the safety and abuse potential of mixing these medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
alprazolam (Xanax) and oxycodone (Percocet, Roxicodone)
What this could lead to
If successful, this could help doctors understand the risks of combining these drugs, leading to safer prescribing guidelines.
What could go wrong
This is an early-phase study with only 25 participants, so results may not apply to everyone. The drugs are given experimentally and may cause side effects like drowsiness or breathing problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40508, United States

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