NCT05585788

Brief Summary

This research study will evaluate the use of, and participants experience with, a new device called Addinex that safely stores and dispenses opioid medication. The purpose of this study is to evaluate the use of the Addinex device in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery. Participants will be asked to answer questions about their medical history and background, fill out questionnaires, use a mobile application associated with the device, and undergo a phone interview one month after stopping use of the device. This study aims to find out how participants like using the Addinex device as opposed to a traditional pill bottle. Results of this study will help determine if the Addinex device could be useful to patients in the future after surgeries, as opposed to typical pill bottles.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

5.6 years

First QC Date

March 9, 2022

Last Update Submit

May 27, 2025

Conditions

Opioid UseBreast Cancer

Outcome Measures

Primary Outcomes (2)

  • Rate of Device Return

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

    12 weeks

  • Rate of Unused Pill Disposal

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

    12 weeks

Secondary Outcomes (8)

  • Median Pill Consumption

    12 weeks

  • Duration of Opioid Use

    12 weeks

  • Opioid Refill Rate

    12 weeks

  • Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days

    Baseline and Day 3

  • Change in Brief Pain Inventory (BPI) Score Baseline and 7 Days

    Baseline and Day 7

  • +3 more secondary outcomes

Study Arms (1)

Addinex system

OTHER

The Addinex system is designed to dispense opioid medication to patients on a provider-determined schedule, to track patient use of the device, and to allow for return and disposal of unused opioids. This study will determine the feasibility of using Addinex for these purposes.

Device: Addinex Device (ADX-27)

Interventions

Addinex Device (ADX-27)DEVICE

The device operates without the use of any electronics, wireless or firmware requirements. This is achieved through its mechanical system which uses a different randomized "passcode" for each dose that is loaded into a circular drum inside the device. The "passcodes" are provided by an online server through either a mobile app, web app, text service or call in service. The online server provides "passcodes" on a request basis, while following instructions set by the treating physicians.

Addinex system

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dawn Hershman, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: To assess the impact of a password-protected pill-dispensing system, Addinex, on unused opioid disposal, opioid use, and opioid refills rates after cancer-related surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Division of Hematology/Oncology

Study Record Dates

First Submitted

March 9, 2022

First Posted

October 19, 2022

Study Start

October 5, 2020

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)