Controlled opioid dispenser and smartphone app for people leaving the emergency room with fractures
Integration of an Opioid Dispensing, Monitoring, and Disposal Platform With a Hospital Pharmacy to Reduce Opioid Use by Discharged Emergency Department Patients
NA · Addinex Technologies, Inc. · NCT06592378
This will try a locked medication dispenser paired with a smartphone app to help people aged 6 and older leaving the emergency department with isolated bone fractures use fewer opioids and return unused pills safely.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Addinex Technologies, Inc. (industry) |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06592378 on ClinicalTrials.gov |
What this trial studies
Participants discharged from the emergency department with isolated bone fractures and a prescription for opioids receive either the Addinex closed-loop dispenser filled by a partner pharmacy or a standard pill bottle. The Addinex system uses a smartphone app to unlock individual doses, delivers education and feedback, and provides a DEA-approved mailer for returning unused pills. The study tracks opioid consumption, excess pill disposal, predictors of use, and patient acceptability. Outcomes for the Addinex group will be compared to those receiving standard pill bottles.
Who should consider this trial
Good fit: Ideal candidates are people age 6 or older with an isolated bone fracture who are sent home from the ED, are not daily opioid users, can give consent (or have a consenting parent), speak English or Spanish, and own and can use a compatible smartphone with internet access.
Not a fit: Patients who are admitted to the hospital, already use opioids daily or recently, lack a compatible smartphone or internet access, have impaired decisional capacity, or are in police/state custody are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the system could reduce how many opioid pills patients take and make it much easier to safely return unused medication.
How similar studies have performed: A small Columbia University study in 30 post-surgical cancer patients using the Addinex system reported about 70% fewer pills used, 60% fewer refills, and an 84% excess-pill disposal rate, indicating promising early results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital/Lifespan — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Study coordinator: Geoffrey Capraro, MD, MPH
- Email: Geoffrey_Capraro@brown.edu
- Phone: 508-410-2215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone Fractures, opioids, fractures, pain