Opioid Dispensing Device for Post-Operative Pain in Cancer Patients Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Opioid Use
• Intervention / Treatment: Device: Addinex Device (ADX-27)

Detailed Description

This is a non-randomized pilot study to test the use of the Addinex system among participants receiving opioids following surgery. The Addinex system is designed to dispense opioid medication to participants on a provider-determined schedule, to track participant 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Nurse Navigator; Phone Number: 212-342-5162; Email: cancerclinicaltrials@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Contact: Dawn Hershman, MD; Phone Number: 212-305-1945; Email: dlh23@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Pill Consumption	Median opioid consumption will be deduced from the number of password requests. Number, date and time of participant password requests are logged on an online database maintained by Addinex.	12 weeks
Duration of Opioid Use	Opioid Use Duration will be measured in days and deduced from the dates of password requests. Number, date and time of participant password requests are logged on an online database maintained by Addinex.	12 weeks
Opioid Refill Rate	Opioid refill rates will be determined through review of electronic medical records and state prescription monitoring programs.	12 weeks
Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days	The quality of pain control will be measured using BPI, which measures two domains: pain severity and pain interference on daily activities. Scores range from 0 to 10 with lower score indicating a better outcome.	Baseline and Day 3
Change in Brief Pain Inventory (BPI) Score Baseline and 7 Days	The quality of pain control will be measured using BPI, which measures two domains: pain severity and pain interference on daily activities. Scores range from 0 to 10 with lower score indicating a better outcome.	Baseline and Day 7
Change in Brief Pain Inventory (BPI) Score Baseline and 3 Weeks	The quality of pain control will be measured using BPI, which measures two domains: pain severity and pain interference on daily activities. Scores range from 0 to 10 with lower score indicating a better outcome.	Baseline and Week 3
Post Study System Usability Questionnaire (PSSUQ) Score	Device usability will be measured by the PSSUQ questionnaire, a 19-item scale. Scores range from 1 (strongly agree) to 7 (strongly disagree) with lower score indicating greater usability.	3 weeks
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) Scores	Acceptability, appropriateness, and feasibility will be measured by combining AIM, IAM, and FIM scale scores. The combination of these scales demonstrates strong psychometric properties and is being used in other cancer-related and technology-based intervention research. Scores range from 1 (Strongly Disagree) to 5 (Completely Agree) with a higher score indicating a better outcome.	3 weeks

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Dawn Hershman, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AAAS8214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes