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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Fractures
• Intervention / Treatment: Device: Standard Pill Bottle; Device: Addinex

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geoffrey Capraro, MD, MPH; Phone Number: 508-410-2215; Email: Geoffrey_Capraro@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital/Lifespan
      • Contact: Geoffrey Capraro, MD, MPH; Phone Number: 508-410-2215; Email: Geoffrey_Capraro@brown.edu
      • Contact: Tanushree Girish, MPH; Phone Number: 401-606-9814; Email: tgirish@brownhealth.org
      • Principal Investigator: Geoffrey Capraro, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Device: Standard Pill Bottle; Access and use of opioids in a standard pill bottle.
Active Comparator: 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)	Device: Standard Pill Bottle; Access and use of opioids in a standard pill bottle.
Experimental: 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)	Device: Addinex; Medication dispensing system to control and monitor opioid use
Experimental: 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)	Device: Addinex; Medication dispensing system to control and monitor opioid use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median pill consumption	Patients are expected to consume at least 16% fewer pills/MMEs using the Addinex system as compared to the control group.	One month post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median disposal of opioids	Patients are expected to dispose of at least 50% of excess opioid pills using the Addinex system vs. 20% in the control group.	12 months post treatment

Collaborators and Investigators

• Sponsor: Addinex Technologies, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pain; fractures; opioids
• Additional Relevant MeSH Terms: Neurologic Manifestations; Wounds and Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Fractures, Bone
• Other Study ID Numbers: 1R43DA060717-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No