Opioid Dispensing Device for Post-Operative Pain in Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorColumbia University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.).
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Addinex Device (ADX-27)
DeviceThe device operates without the use of any electronics, wireless or firmware requirements. This is achieved through its mechanical system which uses a different randomized "passcode" for each dose that is loaded into a circular drum inside the device. The "passcodes" are provided by an online server through either a mobile app, web app, text service or call in service. The online server provides "passcodes" on a request basis, while following instructions set by the treating physicians.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Addinex systemOther 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Device Return
The rate of device return will be determined by an online logging of returned devices by a medical waste disposal company.
Time frame
12 weeks2
Rate of Unused Pill Disposal
The number of unused pills disposed will be deduced based on the number of passwords requested from returned devices.
Time frame
12 weeksSecondary outcomes
1
Median Pill Consumption
Median opioid consumption will be deduced from the number of password requests. Number, date and time of participant password requests are logged on an online database maintained by Addinex.
Time frame
12 weeks2
Duration of Opioid Use
Opioid Use Duration will be measured in days and deduced from the dates of password requests. Number, date and time of participant password requests are logged on an online database maintained by Addinex.
Time frame
12 weeks3
Opioid Refill Rate
Opioid refill rates will be determined through review of electronic medical records and state prescription monitoring programs.
Time frame
12 weeks4
Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days
The quality of pain control will be measured using BPI, which measures two domains: pain severity and pain interference on daily activities. Scores range from 0 to 10 with lower score indicating a better outcome.
Time frame
Baseline and Day 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov