Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05790551 |
| Other study ID # |
R43CE003533 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2024 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Addinex Technologies, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to evaluate the usability and acceptability of the Addinex system
with patients receiving Suboxone in OUD treatment. The main questions it aims to answer are:
- Are patients more likely to stay on their medication?
- Is the risk of diversion being reduced?
- How is the usability of the Addinex system for doctors and patients?
Description:
Prescription opioids remain a popular drug class with 142 million (M) opioid prescriptions
written in 2020. In that same year, 9.5M people aged 12 or older misused opioids representing
3.3% of that population and overdose deaths from opioids rose to 70,029, an increase of 37%
(which has since increased to 82,310 in 2021). The COVID-19 pandemic has exposed many
vulnerabilities in the treatment of patients with OUD. Of patients prescribed opioids,
between 3-10% will later develop opioid use disorder (OUD). Given that prescription opioids
remain the dominant route through which OUD begins, reducing their abuse and diversion can
translate over time into reduced deaths.
Many patients with OUD are treated by a combination of buprenorphine with counseling and
behavioral therapies, also known as Medication Assisted Treatment (MAT). Although
buprenorphine is less addictive than opioids or other treatments (e.g., methadone), it is not
invulnerable to abuse or diversion. There is therefore a significant opportunity for the
development of new technologies aimed at remotely treating OUD, and preventing drug misuse,
abuse, and diversion. Although several secure dispenser technologies are under development,
there remains a critical need for a comprehensive solution that prevents and/or treats
addiction, tracks usage, collects data, and eliminates excess medication, while also
remaining modular and cost effective enough to be widely accessible.
Addinex Technologies, Inc. is developing the only solution that combines: 1) a patented,
secure, low-cost and modular medication-dispenser which controls medication access and
encourages convenient and safe unused medication disposal, combined with 2) companion mobile
patient app and physician/pharmacist web-based software that features interactive modules and
surveys to improve patient education and engagement, caregiver monitoring, and teletherapy to
facilitate patient-provider interactions.
Addinex will conduct a feasibility and acceptability study for its app-based and text-based
system across patients (n = 60) undergoing OUD treatment. Successful completion of these aims
will provide critical insights to further optimize the Addinex system and to guide the design
of a larger, randomized controlled trial to demonstrate its efficacy and cost effectiveness.
This study will be the springboard for the development of a system that is cost efficient,
widely accessible, and user-friendly, with the aim of increasing adherence, decreasing
treatment time, decreasing the misuse of medication, increasing treatment retention, and
reducing relapses in OUD treatment for the many who are suffering.
