NCT05585788 Opioid Dispensing Device for Post-Operative Pain in Cancer Patients
| NCT ID | NCT05585788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Opioid Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2020-10-05 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2020-10-05 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Dawn Hershman, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05585788 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Opioid Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05585788 currently recruiting?
Yes, NCT05585788 is actively recruiting participants. Contact the research team at cancerclinicaltrials@cumc.columbia.edu for enrollment information.
Where is the NCT05585788 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05585788 clinical trial?
NCT05585788 is sponsored by Columbia University. The principal investigator is Dawn Hershman, MD at Columbia University. The trial plans to enroll 140 participants.