Opioid Management for Discharged Emergency Department Patients

NCT06592378 | Recruiting FDA Device

• 1 other identifier: 1R43DA060717-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Fractures

Keywords

opioids; fractures; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Median disposal of opioids

  12 months post treatment

Study Arms (4)

Control Adult

ACTIVE COMPARATOR

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

Control Child

ACTIVE COMPARATOR

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

Device Adult

EXPERIMENTAL

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

Device Child

EXPERIMENTAL

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

Interventions

Addinex DEVICE

Medication dispensing system to control and monitor opioid use

Device Adult; Device Child

Standard Pill Bottle DEVICE

Access and use of opioids in a standard pill bottle.

Control Adult; Control Child

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Addinex Technologies, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rhode Island Hospital/Lifespan

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Geoffrey Capraro, MD, MPH

CONTACT

508-410-2215; Geoffrey_Capraro@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: June 27, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)