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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585788
• Other study ID #: AAAS8214
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: May 1, 2026

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: Research Nurse Navigator
• Phone: 212-342-5162
• Email: cancerclinicaltrials[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Opioid Use

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Opioid Refill Rate	Opioid refill rates will be determined through review of electronic medical records and state prescription monitoring programs.	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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