Opioid Management for Discharged Emergency Department Patients
ConditionBone Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorAddinex Technologies, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages six years and older
Ability to swallow pills
Isolated bone fracture
Planned to receive opioids in the post-treatment period
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Addinex
DeviceMedication dispensing system to control and monitor opioid use
Standard Pill Bottle
DeviceAccess and use of opioids in a standard pill bottle.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Control AdultActive comparator 1 intervention
Group B: Control ChildActive comparator 1 intervention
Group C: Device AdultExperimental treatment 1 intervention
Group D: Device ChildExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
One month post treatmentSecondary outcomes
1
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.
Time frame
12 months post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Addinex Technologies, Inc.
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov