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Opioid Management for Discharged Emergency Department Patients

Integration of an Opioid Dispensing, Monitoring, and Disposal Platform With a Hospital Pharmacy to Reduce Opioid Use by Discharged Emergency Department Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06592378
Enrollment
100
Registered
2024-09-19
Start date
2025-06-27
Completion date
2026-06-30
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Fractures

Keywords

opioids, fractures, pain

Brief summary

The goal of this study is to analyze the use of the Addinex system for opioid dispensing after ambulatory care to determine whether it will reduce opioid consumption, increase pill disposal, show variables that may predict opioid consumption, and determine whether this intervention is acceptable to patients.

Detailed description

Prescription opioids remain a popular drug class with 143 million (M) opioid prescriptions written in 2020. In that same year, 8.7 million people (2.6% of the US population) misused prescription pain relievers, and overdose deaths from opioids continue to rise to 83,695 in 2022. Across six studies, 67% to 92% of patients prescribed opioids reported unused pills. In 2017, patients were prescribed 3.3 billion excess pills, yet no more than 9% of patients properly disposed of their unused opioids. Despite attempts to reduce overprescribing, increase disposal, and decrease diversion, these issues still contribute to increasing misuse, addiction, and overdose deaths. 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.

Interventions

DEVICEAddinex

Medication dispensing system to control and monitor opioid use

DEVICEStandard Pill Bottle

Access and use of opioids in a standard pill bottle.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Addinex Technologies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Ages six years and older * 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

* Recent opioid use (last 30 days or 2 or more prescriptions in the past 3 months * Impaired decisional capacity * In police custody * Ward of the state

Design outcomes

Primary

MeasureTime frameDescription
Median pill consumptionOne month post treatmentPatients are expected to consume at least 16% fewer pills/MMEs using the Addinex system as compared to the control group.

Secondary

MeasureTime frameDescription
Median disposal of opioids12 months post treatmentPatients are expected to dispose of at least 50% of excess opioid pills using the Addinex system vs. 20% in the control group.

Countries

United States

Contacts

Primary ContactGeoffrey Capraro, MD, MPH
Geoffrey_Capraro@brown.edu508-410-2215

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026