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

NCT ID: NCT05585788Sponsor: Columbia UniversityLast updated: 2025-05-31

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.

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.

Arms & 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.

Outcome measures

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.

    Time frame: 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.

    Time frame: 12 weeks

Secondary

  • Median Pill Consumption

    Time frame: 12 weeks

  • Duration of Opioid Use

    Time frame: 12 weeks

  • Opioid Refill Rate

    Time frame: 12 weeks

  • Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days

    Time frame: Baseline and Day 3

  • Change in Brief Pain Inventory (BPI) Score Baseline and 7 Days

    Time frame: Baseline and Day 7

  • Change in Brief Pain Inventory (BPI) Score Baseline and 3 Weeks

    Time frame: Baseline and Week 3

  • Post Study System Usability Questionnaire (PSSUQ) Score

    Time frame: 3 weeks

  • Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) Scores

    Time frame: 3 weeks

Eligibility criteria

Sex: AllAge: 18 Years to 99 YearsHealthy volunteers: No
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 locations (1)

Columbia University Medical Center

New York, New York, 10032

Recruiting
Dawn Hershman, MD · Contact
Opioid Dispensing Device for Post-Operative Pain in Cancer Patients | Cancerify