Clinical trial NCT05585788: Opioid Dispensing Device for Post-Operative Pain in Cancer Patients
Official title: Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Breast Cancer
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Rate of Device Return
timeFrame: 12 weeks
measure: Rate of Unused Pill Disposal
timeFrame: 12 weeks
Secondary outcomes:
measure: Median Pill Consumption
timeFrame: 12 weeks
measure: Duration of Opioid Use
timeFrame: 12 weeks
measure: Opioid Refill Rate
timeFrame: 12 weeks
measure: Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days
timeFrame: Baseline and Day 3
measure: Change in Brief Pain Inventory (BPI) Score Baseline and 7 Days
timeFrame: Baseline and Day 7
measure: Change in Brief Pain Inventory (BPI) Score Baseline and 3 Weeks
timeFrame: Baseline and Week 3
measure: Post Study System Usability Questionnaire (PSSUQ) Score
timeFrame: 3 weeks
measure: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) Scores
timeFrame: 3 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn Hershman, MD
role: PRINCIPAL_INVESTIGATOR
References: