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Can stress make painkillers more risky? new study investigates

NCT ID NCT05142267

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 1 time

Summary

This study looks at how stress changes the way opioid painkillers work in people with chronic back pain. Researchers will give participants oxycodone, a pain blocker, or a placebo in a lab setting to measure pain relief and drug liking. The goal is to understand why some people may be at higher risk for misusing pain medications when stressed.

What this could mean

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

Active substance
Oxycodone and naloxone (given in controlled lab sessions to study pain response)
What this could lead to
If successful, this study could help identify why some people are more likely to misuse opioid painkillers, leading to better prevention strategies.
What could go wrong
This is an early-stage observational study with only 120 participants. Results may not apply to everyone, and the lab setting may not reflect real-world stress and pain.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

101 people

The number who actually took part.

Started

Mar 2022

Finished

Apr 2026

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 years and older

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: * Intact cognitive status and ability to provide informed consent * Ability to read and write in English sufficiently to understand and complete study questionnaires (which are only validated in English) * Age 18 or older And * Presence of persistent daily low back pain of at least three months duration and of at least a 3/10 in average intensity Exclusion Criteria: * History of renal or hepatic dysfunction * Reports of current or past alcohol or substance abuse or treatment for such condition * A reported history of PTSD, psychotic, or bipolar disorders * Chronic pain due to malignancy (e.g., cancer) or autoimmune disorders (e.g., rheumatoid arthritis, lupus) * Reports of recent benzodiazepine use (confirmed via rapid urine screening prior to each lab session) * Any medical conditions (e.g., significant cardiovascular disease) that the study physician feels would contraindicate participation in the lab stressors * Reported daily opiate use within the past 6 months, or use of any opioid analgesic medications within 3 days of study participation (confirmed through rapid urine screening prior to each lab session) * Pregnancy (females only, to avoid fetal drug exposure - pregnancy tests conducted prior to each lab session to confirm eligibility) * Prior allergic reaction/intolerance to oxycodone or its analogs

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Conditions

The condition(s) this trial relates to.

Back Pain opiate dependence

As listed by the trial registrant

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

Back pain Opioid-use disorder Stress

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.