Opioid Management for Discharged Emergency Department Patients
NCT ID: NCT06592378
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-06-27
2026-06-30
Brief Summary
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Detailed Description
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Addinex Technologies has developed a novel system to reduce the use of opioids through controlling, monitoring, and disposing of excess opioids. The unique "closed-loop" system starts with clinicians prescribing opioids with the Addinex system. Addinex's partner pharmacy then fills the patented dispenser and delivers it to the patient. The patient uses the Addinex app to access each individual dose code and to obtain education and feedback. Finally, the patient returns the dispenser with any excess pills in a DEA-approved mailer to Addinex's partner disposal company. In a study with Columbia University Medical Center using the Addinex system with 30 post-surgical cancer patients, results showed 70% fewer pills used than prescribed, 60% fewer refills for the same surgeries, and an 84% excess pill disposal rate.
Addinex is now partnering with Brown Emergency Medicine and Rhode Island Hospital ("Brown") to perform a feasibility study using Addinex\'s system. We will conduct a clinical trial involving 100 patients with extremity fractures treated by the emergency department. Half the patients (25 adults and 25 minors) will utilize the Addinex system, while the other half will have their opioids dispensed in a standard pill bottle as the control group. Addinex's system promotes the return of medication using a pre-paid disposal mailer once patients have completed their course of treatment. The clinical study\'s main goals involve evaluating the system\'s effectiveness with patients obtaining same day treatment. This evaluation will encompass an analysis of medication consumption, disposal rates, pain levels, the impact of monitoring policies, and ensuring that the established commercial protocols function seamlessly. Ultimately, the project aims to demonstrate that the Addinex system can successfully operate within the broader hospital environment (same day and scheduled procedures), controlling and monitoring opioid usage, promoting patient well-being, and lowering costs.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Device Adult
Patients in this arm will be adults who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25)
Addinex
Medication dispensing system to control and monitor opioid use
Device Child
Patients in this arm will be children who undergo at-home acute pain management using the Addinex system after treatment for isolated bone fracture (n=25)
Addinex
Medication dispensing system to control and monitor opioid use
Control Adult
Patients in this arm will be adults who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25)
Standard Pill Bottle
Access and use of opioids in a standard pill bottle.
Control Child
Patients in this arm will be children who undergo standard at-home acute pain management with opioids after treatment for isolated bone fracture (n=25)
Standard Pill Bottle
Access and use of opioids in a standard pill bottle.
Interventions
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Addinex
Medication dispensing system to control and monitor opioid use
Standard Pill Bottle
Access and use of opioids in a standard pill bottle.
Eligibility Criteria
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Inclusion Criteria
* Ability to swallow pills
* Isolated bone fracture
* Planned to receive opioids in the post-treatment period
* Not taking opioids daily prior to the procedure
* English or Spanish-speaking
* Able to give informed consent or a parent that can give informed consent
* Ownership of and comfort using apps on a smartphone with compatible operating system
* WIFI or cellular access
* Patient not admitted to hospital
Exclusion Criteria
* Impaired decisional capacity
* In police custody
* Ward of the state
6 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Addinex Technologies, Inc.
INDUSTRY
Responsible Party
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Locations
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Rhode Island Hospital/Lifespan
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Geoffrey Capraro, MD, MPH
Role: primary
Tanushree Girish, MPH
Role: backup
Other Identifiers
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