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New patch could cut opioid addiction after ankle surgery

NCT ID NCT06949826

Symptom relief Sponsor: Jenna-Leigh Wilson Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a 7-day buprenorphine skin patch can safely control pain after ankle fracture surgery and reduce the need for addictive opioids. About 100 adults who have never taken opioids before will receive either the real patch or a placebo, along with standard pain care. Researchers will track pain levels, opioid use, and whether participants still need opioids 3 months later.

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

About 100 people

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

Started

Apr 2025

Expected to finish

Jun 2027

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 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: * Patient is 18 years of age or older * Patient is undergoing single stage ORIF of an ankle fracture * Patient is English-speaking EXCLUSION CRITERIA: * Patient is under 18 years of age * Patient's ankle fracture is treated with external fixation * Patient has a concomitant osseous or visceral injury * Patient has a history of opioid use disorder or a current diagnosis of opioid use disorder * Patient has a history of alcohol use disorder or a current diagnosis of alcohol use disorder * Patient was taking opioid medication or narcotic drugs prior to their injury * Patient has a current active malignancy * Patient is taking a medication that carries a prohibitively high risk of drug-drug interaction with buprenorphine, hydrocodone, or oxycodone in the view of their treating physician or nurse anesthetist * Patient has an anaphylactic allergy to buprenorphine, hydrocodone, or oxycodone * Patient is not English-speaking * Patient is pregnant * Patient is unable to complete pain diary or communicate pain scores * Patient is incarcerated * Patient has a Gustilo-Anderson Type III open fracture

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Conditions

The condition(s) this trial relates to.

Ankle Fractures opiate dependence Pain, Postoperative

As listed by the trial registrant

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

Ankle fracture surgery Opioid analgesia Opioid dependence Opioid-use disorder Pain, postoperative

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

  • Washington University in St. Louis/Barnes Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

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