Suboxone Dispenser for OUD

May 22, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Connecticut
      • Greenwich, Connecticut, United States, 06830
        • Greenwich Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
Patients in this arm will undergo standard at-home OUD treatment (n = 5/group) over 14-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 = 5/group) over 14-days.
Device: Addinex
Medication dispensing system for Suboxone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Drug Test for Opioid Use Disorder (Quest 12-Panel Drug Screen)
Time Frame: Up to two weeks
Urine analysis will be completed on a biweekly basis for the research study
Up to two weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS Self-Efficacy Scale
Time Frame: Up to two weeks
Evaluation of participants' self-efficacy toward change over the course of the study
Up to two weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Addinex Technologies, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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