Device for dispensing opioids after cancer surgery
Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery
This study tests a new device that gives cancer patients their pain medication after surgery to see if it's easier and safer to use than regular pill bottles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05585788 on ClinicalTrials.gov |
What this trial studies
This research evaluates the Addinex device, which safely stores and dispenses opioid medication for cancer patients post-surgery. Participants will provide medical history, complete questionnaires, and use a mobile app linked to the device. The study aims to compare the user experience of the Addinex device with traditional pill bottles. It will also assess the feasibility of the device in managing opioid use after cancer-related surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing major cancer-related surgery who will require postoperative opioid pain management.
Not a fit: Patients who are already taking opioids daily before surgery or those unable to use the device will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could improve pain management and safety for cancer patients recovering from surgery.
How similar studies have performed: While the specific Addinex device approach is novel, similar studies on opioid management devices have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Dawn Hershman, MD — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.