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New smart pill dispenser aims to curb opioid misuse after surgery

NCT ID NCT06358040

Symptom relief Sponsor: Hospital for Special Surgery, New York 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests a new device that only releases opioid pills at set times after spine surgery, aiming to reduce misuse and side effects. Half of the 30 participants will use the device and an app, while the other half get a standard pill bottle and app. Researchers will track pain scores and opioid use for two weeks after surgery to see if the device helps patients take opioids more safely.

What this could mean

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

Active substance
Opioid-Dispensing Device (Addinex)
What this could lead to
If successful, this device could help patients take opioids more safely after surgery, reducing the risk of addiction and side effects.
What could go wrong
This is a very small pilot study with only 30 patients, so results may not apply to everyone. The device may be inconvenient or not improve safety as hoped.

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 30 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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: * opioid-naive patients or intermittent opioid users within 3 months of scheduled surgery * At least 18 years old * presenting for primary elective one-level lumbar laminectomy and/or discectomy via posterior approach with participating surgeon * planned discharge on day of surgery/23 hour admission * planned discharge to home Exclusion Criteria: * patients with opioid-tolerance * patients without a smart-phone or without the ability to perform Telehealth visits * patients unable to utilize the medication dispensing device * patients presenting for other surgeries/surgeries with combined anterior/lateral approaches * patient refusal * allergy or intolerance to opioids * planned admission after surgery * planned discharge disposition to nursing facility or skilled rehabilitation * planned use of or preference for opioid other than oxycodone * patients who are pregnant

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Conditions

The condition(s) this trial relates to.

opioid abuse Pain, Postoperative

As listed by the trial registrant

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

Diskectomy Laminectomy Medical device Opioid use 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

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

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