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NCT Number: NCT05585788

Opioid Dispensing Device for Post-Operative Pain in Cancer Patients

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.

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Key information

Conditions

Opioid Use Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Dawn Hershman, MD

CONTACT

[email protected]

212-305-1945

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Addinex Device (ADX-27)

Device

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.

Primary outcomes

  1. Rate of Device Return

    Time frame: 12 weeks

    The rate of device return will be determined by an online logging of returned devices by a medical waste disposal company.

  2. Rate of Unused Pill Disposal

    Time frame: 12 weeks

    The number of unused pills disposed will be deduced based on the number of passwords requested from returned devices.

Secondary outcomes

  1. Median Pill Consumption

    Time frame: 12 weeks

    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.

  2. Duration of Opioid Use

    Time frame: 12 weeks

    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.

  3. Opioid Refill Rate

    Time frame: 12 weeks

    Opioid refill rates will be determined through review of electronic medical records and state prescription monitoring programs.

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

    Time frame: Baseline and Day 3

    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.

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

    Time frame: Baseline and Day 7

    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.

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

    Time frame: Baseline and Week 3

    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.

  7. Post Study System Usability Questionnaire (PSSUQ) Score

    Time frame: 3 weeks

    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.

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

    Time frame: 3 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Research Nurse Navigator

CONTACT

[email protected]

212-342-5162

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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