Opioid Dispensing Device for Post-Operative Pain in Cancer Patients

Columbia University

Status: Enrolling

Conditions: Breast Cancer; Opioid Use

Treatments: Device: Addinex Device (ADX-27)

Study type: Interventional

Funder types: Other

Identifiers

NCT05585788

AAAS8214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Addinex system

Other group

Description:

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.

Treatment:

Device: Addinex Device (ADX-27)