Clinical trial · Interventional
Opioid Dispensing Device for Post-Operative Pain in Cancer Patients
Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Opioid Use | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Addinex Device (ADX-27) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Addinex system
- 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.
- interventionNames
- Device: Addinex Device (ADX-27)
Primary outcomes (2)
- measure
- Rate of Device Return
- timeFrame
- 12 weeks
- description
- The rate of device return will be determined by an online logging of returned devices by a medical waste disposal company.
- measure
- Rate of Unused Pill Disposal
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available