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

Plain Language Summary

Simplified for easier understanding

This study is testing a controlled opioid dispensing device to help cancer patients manage pain safely after major surgery. The device is designed to dispense opioid pain medication in a controlled way to reduce the risk of overuse or misuse while still keeping patients comfortable. **You may be eligible if...** - You are 18 or older - You are scheduled for major cancer-related surgery and are expected to receive opioid pain medications afterward - You speak English or Spanish - You have access to a smartphone or similar smart device (iPhone, Android, iPad, etc.) **You may NOT be eligible if...** - You take opioid medications daily before your surgery - You are unable to physically use the device or take your own medications - You are not comfortable using smartphone or tablet technology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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.

Locations(1)

Columbia University Medical Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05585788

Related Trials

Genomic Services Research Program

NCT025959571 location

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

NCT052833304 locations

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

NCT070671381 location

Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)

NCT068852031 location

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

NCT06103864316 locations