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Addinex Device for Post-Surgery Opioid Management in Cancer Patients

This study is testing a new device called Addinex (ADX-27) that safely stores and dispenses opioid medication. It's designed to help manage pain after cancer surgery. The Addinex device works mechanically, without electronics, using a unique "passcode" for each dose. We want to see how well participants like using this device compared to a regular pill bottle. We'll measure how many devices are returned and how much unused medication is disposed of after 12 weeks. You may be able to join if you are an adult (18-99 years old) having major cancer surgery, expect to receive opioids for pain, speak English or Spanish, and have a smartphone or similar smart device. The study is currently unclear on its recruitment status and plans to enroll 140 participants.

Study design
This is a non-randomized pilot study to test the Addinex system. It aims to enroll 140 participants.
What's involved
You will answer questions about your medical history, fill out questionnaires, use a mobile app with the device, and have a phone interview one month after you stop using the device.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at 12 weeks and includes a phone interview one month after you stop using the device.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05585788

Opioid Dispensing Device for Post-Operative Pain in Cancer Patients

Recruiting
NAAges 18–99InterventionalPrevention
Columbia University
~140 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Addinex Device (ADX-27)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Device Return
Measured over 12 weeks
+1 more outcome measured

Conditions

Opioid Use
Breast Cancer

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Breast Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Dawn Hershman, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Research Nurse Navigator
[email protected]
212-342-5162
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult patients (age greater than or equal to 18 years)
Planned for major cancer-related surgery and expected to receive a postoperative opioid prescription
Must speak English or Spanish
Must have access to a smartphone or an alternative smart device (e.g., iPhone, Android phone, iPad, Surface, etc.).
Co-enrollment in trials involving pharmacologic therapy is allowed

Exclusion

Patients who are taking opioids daily prior to the surgical procedure
Patients unable to physically utilize the device
Patients unable to self-administer medications
Patients uncomfortable with using iPhone or iPad-based technology

What this trial measures

  • Rate of Device Return12 weeks

    The rate of device return will be determined by an online logging of returned devices by a medical waste disposal company.

  • Rate of Unused Pill Disposal12 weeks

    The number of unused pills disposed will be deduced based on the number of passwords requested from returned devices.