RecruitingNot ApplicableNCT05585788

Opioid Dispensing Device for Post-Operative Pain in Cancer Patients

Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery

Sponsor

Columbia University

Enrollment

140 participants

Start Date

Oct 5, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Opioid Use

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria5

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 Criteria4

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

Interventions

DEVICEAddinex 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.