Opioid Use DisorderNCT05790551
Suboxone Dispenser for OUD
A study testing Addinex in people with Opioid Use Disorder and Opioid Withdrawal, run by Addinex Technologies, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Withdrawal
- What is being tested?
- Addinex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Opioid Use Disorder, Opioid Withdrawal
- Being tested
- Addinex
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AddinexDevice
Medication dispensing system for Suboxone
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in this arm will undergo standard at-home OUD treatment (n = 5/group) over 14-days. Receives: Device: Addinex |
| Active - App | Experimental | 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. Receives: Device: Addinex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Test for Opioid Use Disorder (Quest 12-Panel Drug Screen)
Urine analysis will be completed on a biweekly basis for the research study
Measured: Up to two weeks
Secondary outcomes (1)
PROMIS Self-Efficacy Scale
Evaluation of participants' self-efficacy toward change over the course of the study
Measured: Up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start15 Jan 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Why it stopped: Study was discontinued at the primary site due to change in site management.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addinex Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790551
- Sponsor's protocol ID
- R43CE003533
- Status last verified
- May 2025
- First submitted
- 24 Feb 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Telehealth Medication-assisted Treatment (MAT) System for Patients With Opioid Use Disorder (OUD)
- ClinicalTrials.gov ID
- NCT05790551
- Acronym / sponsor ID
- R43CE003533
- Conditions
- Opioid Use Disorder, Opioid Withdrawal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was discontinued at the primary site due to change in site management.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Addinex Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: AddinexPatients in this arm will undergo standard at-home OUD treatment (n = 5/group) over 14-days. |
| Active - App | Experimental | Device: AddinexPatients in this arm will undergo standard at-home OUD treatment in combination with the Addinex dispenser and app (n = 5/group) over 14-days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AddinexMedication dispensing system for Suboxone | Device | Active - App, Control |
Primary outcome
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
1 secondary outcome
PROMIS Self-Efficacy Scale
Time frame: Up to two weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addinex in people with Opioid Use Disorder and Opioid Withdrawal, run by Addinex Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Test for Opioid Use Disorder (Quest 12-Panel Drug Screen) (time frame: Up to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.