Recruiting

Opioid Dispensing Device

Sponsor:

Columbia University

Code:

NCT05585788

Conditions

Opioid Use

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Addinex Device (ADX-27)

Study Details

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.

Conditions

Opioid Use

Breast Cancer

Study ID

NCT05585788

Start date

Oct 5, 2020

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Addinex system

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.

Interventions

Addinex Device (ADX-27)

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.

Primary outcome measure

  • Rate of Device Return [ Time Frame: 12 weeks ]
  • Rate of Unused Pill Disposal [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Research Nurse Navigator

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

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Dawn Hershman, MD

212-305-1945dlh23@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-07-10.