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New device aims to cut opioid use after fractures

NCT ID NCT06592378

Symptom relief Sponsor: Addinex Technologies, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a device called Addinex that controls and monitors opioid use after a bone fracture. About 100 people will either use the device or a standard pill bottle. The goal is to see if the device helps people take fewer opioids and dispose of leftover pills more often.

What this could mean

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

Active substance
Addinex medication dispensing system
What this could lead to
If it works, this could give doctors a new tool to help patients use fewer opioids after a bone fracture and dispose of leftover pills properly.
What could go wrong
This is a small early study with only 100 people, so results may not apply to everyone. The device requires a smartphone and comfort with apps, which could limit who can use it.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

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

Started

Jun 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

6 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: * Ages six years and older * Ability to swallow pills * Isolated bone fracture * Planned to receive opioids in the post-treatment period * Not taking opioids daily prior to the procedure * English or Spanish-speaking * Able to give informed consent or a parent that can give informed consent * Ownership of and comfort using apps on a smartphone with compatible operating system * WIFI or cellular access * Patient not admitted to hospital Exclusion Criteria: * Recent opioid use (last 30 days or 2 or more prescriptions in the past 3 months * Impaired decisional capacity * In police custody * Ward of the state

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Conditions

The condition(s) this trial relates to.

bone fracture Pain

As listed by the trial registrant

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

Bone fractures

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

  • Rhode Island Hospital/Lifespan

    RECRUITING

    Providence, Rhode Island, 02903, United States

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