Opioid UseNCT05585788
Opioid Dispensing Device for Post-Operative Pain in Cancer Patients
A study testing Addinex Device (ADX-27) in people with Opioid Use and Breast Cancer, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Use, Breast Cancer
- What is being tested?
- Addinex Device (ADX-27)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Dawn Hershman, MD, 212-305-1945, dlh23@cumc.columbia.edu
About this study
Official title: Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery
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.
Read the detailed 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.
- Conditions
- Opioid Use, Breast Cancer
- Being tested
- Addinex Device (ADX-27)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addinex Device (ADX-27)Device
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Addinex system | Other | 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. Receives: Device: Addinex Device (ADX-27) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Rate of Unused Pill Disposal
The number of unused pills disposed will be deduced based on the number of passwords requested from returned devices.
Measured: 12 weeks
Secondary outcomes (8)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Opioid Refill Rate
Opioid refill rates will be determined through review of electronic medical records and state prescription monitoring programs.
Measured: 12 weeks
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.
Measured: Baseline and Day 3
Change in Brief Pain Inventory (BPI) Score Baseline and 7 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.
Measured: Baseline and Day 7
Change in Brief Pain Inventory (BPI) Score Baseline and 3 Weeks
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.
Measured: Baseline and Week 3
Post Study System Usability Questionnaire (PSSUQ) Score
Device usability will be measured by the PSSUQ questionnaire, a 19-item scale. Scores range from 1 (strongly agree) to 7 (strongly disagree) with lower score indicating greater usability.
Measured: 3 weeks
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) Scores
Acceptability, appropriateness, and feasibility will be measured by combining AIM, IAM, and FIM scale scores. The combination of these scales demonstrates strong psychometric properties and is being used in other cancer-related and technology-based intervention research. Scores range from 1 (Strongly Disagree) to 5 (Completely Agree) with a higher score indicating a better outcome.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start5 Oct 2020
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To assess the impact of a password-protected pill-dispensing system, Addinex, on unused opioid disposal, opioid use, and opioid refills rates after cancer-related surgery.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Dawn L. Hershman, Columbia University
- Investigators
- Dawn Hershman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585788
- Sponsor's protocol ID
- AAAS8214
- Other IDs
- 1R34DA056796-01A1
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes