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

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

Recruiting
18-99 years
All
Phase N/A

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Overview

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.

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

Study details
    Opioid Use
    Breast Cancer

NCT05585788

Columbia University

1 May 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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