Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592378
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Opioid Management for Discharged Emergency Department Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integration of an Opioid Dispensing Monitoring and Disposal Platform with a Hospital Pharmacy to Reduce Opioid Use by Discharged Emergency Department Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 87 million people 26 of the US population misused prescription pain relievers and overdose deaths from opioids continue to rise to 83695 in 2022 Across six studies 67 to 92 of patients prescribed opioids reported unused pills In 2017 patients were prescribed 33 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 Addinexs 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 Addinexs 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 Addinex39s 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 Addinexs system promotes the return of medication using a pre-paid disposal mailer once patients have completed their course of treatment The clinical study39s main goals involve evaluating the system39s 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
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 Addinexs 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 Addinexs 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 Addinex39s 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 Addinexs system promotes the return of medication using a pre-paid disposal mailer once patients have completed their course of treatment The clinical study39s main goals involve evaluating the system39s 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None