Suboxone Dispenser for OUD

January 29, 2024 updated by: Addinex Technologies, Inc.

Development of a Telehealth Medication-assisted Treatment (MAT) System for Patients With Opioid Use Disorder (OUD)

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A minimum of 18 years old at admission of study
  • Primary or secondary diagnosis of opioid use disorder (DSM-5; APA, 2013) diagnosis by clinician
  • Prospective patients have to select 'Yes' they are interested in Yale-approved research studies while enrolled at Aware Recovery Care and that researchers can contact them about research projects

Exclusion Criteria:

  • Meets criterion of DSM-V (APA, 2013) for bi-polar, schizophrenia, or psychiatric disorders
  • Unable to read and understand English at 5th grade level
  • Unable to complete the study because of anticipated incarceration or move
  • Life threatening or unstable medical problems
  • Current suicide or homicide risk
  • Anticipated/current pregnancy, or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Patients in this arm will undergo standard at-home OUD treatment (n = 20/group) over 30-days.
Device: Addinex
Medication dispensing system for Suboxone
Experimental: Active - App
Patients in this arm will undergo standard at-home OUD treatment in combination with the Addinex dispenser and app (n = 20/group) over 30-days.
Device: Addinex
Medication dispensing system for Suboxone
Experimental: Active - Text Messaging
Patients in this arm will undergo standard at-home OUD treatment in combination with the Addinex dispenser and texting (n = 20/group) over 30-days.
Device: Addinex
Medication dispensing system for Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Test for Opioid Use Disorder (Quest 12-Panel Drug Screen)
Time Frame: Up to four weeks
Urine analysis will be completed on a biweekly basis for the research study
Up to four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Self-Efficacy Scale
Time Frame: Up to four weeks
Evaluation of participants' self-efficacy toward change over the course of the study
Up to four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addinex Technologies, Inc.

Collaborators

Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R43CE003533 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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