Recruiting

Addinex

Sponsor:

Addinex Technologies, Inc.

Code:

NCT06592378

Conditions

Bone Fractures

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Addinex

Standard Pill Bottle

Study Details

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

Study ID

NCT06592378

Start date

Jun 27, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

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)

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)

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)

Interventions

Addinex

Medication dispensing system to control and monitor opioid use

Standard Pill Bottle

Access and use of opioids in a standard pill bottle.

Primary outcome measure

  • Median pill consumption [ Time Frame: One month post treatment ]

Central Contacts and Locations

Central contacts

Geoffrey Capraro, MD, MPH

508-410-2215Geoffrey_Capraro@brown.edu

Locations

Rhode Island Hospital/Lifespan

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Geoffrey Capraro, MD, MPH

508-410-2215Geoffrey_Capraro@brown.edu

Tanushree Girish, MPH

401-606-9814tgirish@brownhealth.org

Principal Investigator:

Geoffrey Capraro, MD, MPH

More Information

Sponsor

Addinex Technologies, Inc.

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

  • opioids
  • fractures
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Addinex Technologies, Inc. on 2025-12-26.