Addinex Dispenser for Opioid Use Disorder

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Addinex Technologies, Inc.

Must be taking: Suboxone

Disqualifiers: Bipolar, Schizophrenia, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called Addinex, designed to assist individuals with opioid use disorder who are taking Suboxone. The goal is to determine if this system helps patients adhere to their medication and reduces the risk of misuse. Researchers are also evaluating the system's ease of use and usefulness for both patients and doctors. This study may suit individuals diagnosed with opioid use disorder who are interested in Yale-approved research while receiving treatment at Aware Recovery Care. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could enhance treatment experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves patients already receiving Suboxone, it seems likely that you would continue with that medication.

What prior data suggests that the Addinex system is safe for patients with opioid use disorder?

Research has shown that the Addinex dispenser operates safely in various situations. One study found that 30 post-surgical cancer patients using the Addinex system took 70% fewer pills compared to those not using it, suggesting the system aids in safe medication management.

Another study demonstrated that the Addinex dispenser facilitated the safe disposal of unused opioids, with a high rate of returning unused pills, reducing the risk of misuse.

Overall, different groups have received the Addinex system positively, and these studies have reported no major safety issues, making it a promising tool for managing opioid use safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Addinex Dispenser is unique because it combines standard opioid use disorder (OUD) treatment with a smart dispenser and app, offering a tech-forward approach to managing medication. Unlike traditional methods that rely solely on medication, this system aims to improve adherence and prevent misuse by controlling access to opioids through a personalized dispenser. Researchers are excited about this treatment because it has the potential to enhance treatment outcomes by integrating technology to support patient adherence and reduce the risk of addiction relapse.

What evidence suggests that the Addinex system is effective for opioid use disorder?

Research shows that the Addinex dispenser app may help manage opioid use. In a study with 30 patients, 80% successfully returned the device, and 57% did so within six weeks. The app collected detailed information on opioid use, potentially improving prescription practices. The results also suggested that the system might reduce the need for additional opioid prescriptions and enhance medication disposal. In this trial, one group of participants will use the Addinex dispenser and app alongside standard at-home OUD treatment, while another group will receive only the standard treatment. Although the focus has been on post-surgery patients, these findings suggest it might also assist people with Opioid Use Disorder (OUD) by facilitating safer medication management. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with opioid use disorder who can communicate in English at a 5th grade level. They must be interested in participating in research and not planning to move or be incarcerated during the study. Pregnant, breastfeeding individuals, those with severe psychiatric disorders like bipolar or schizophrenia, high suicide risk, or unstable medical conditions cannot join.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard at-home OUD treatment with or without the Addinex dispenser and app

2 weeks

Biweekly urine analysis

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Addinex

Trial Overview

The Addinex system is being tested to see if it helps patients stick to their Suboxone treatment for opioid use disorder better and reduces medication misuse. The study will assess how easy the system is for both doctors and patients to use.

How Is the Trial Designed?

Group I: Active - App Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

Patients in this arm will undergo standard at-home OUD treatment (n = 5/group) over 14-days.

Who Is Running the Clinical Trial?

Addinex Technologies, Inc.

Lead Sponsor

Trials

2

Recruited

110+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

Sustained release naltrexone (SRX) formulations, which can release the opioid antagonist for 1-7 months, have been shown to effectively reduce heroin use and have an acceptable safety profile based on multiple studies.

SRX not only helps in reducing opioid use but also appears to positively impact other areas such as reducing risky behaviors associated with blood-borne diseases, although more controlled studies are needed to fully understand its effectiveness compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable and implantable sustained release naltrexone in the treatment of opioid addiction. Kunøe, N., Lobmaier, P., Ngo, H., et al.[2021]

Buprenorphine/naloxone has a unique pharmacology that provides a ceiling effect on its cardio-respiratory depressant properties, making it potentially safer than other opioids, especially at higher doses.

Data from various safety monitoring systems indicate that buprenorphine/naloxone has a favorable safety profile compared to other opioids and psychotropic drugs, suggesting it may reduce the risk of overdose-related morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Question About the Safety of Buprenorphine/Naloxone and Benzodiazepine Drugs. Howland, RH.[2015]

A retrospective study of 199 buprenorphine exposure cases from 2009 to 2018 showed that the majority of incidents were related to suicide attempts and overdoses in individuals with substance abuse issues, but no deaths were reported, indicating a relatively safe profile for buprenorphine.

The study found that while neurological symptoms were common (83%), respiratory symptoms were rare (13%), and the severity of most cases was low, with 80% classified as mild, suggesting that buprenorphine has a lower risk of severe respiratory depression compared to other opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine exposures in adolescents and adults: a 10-year experience of a French Poison Control Center. Boulamery, A., von Fabeck, K., Glaizal, M., et al.[2021]

The study utilized the Opioid Attractiveness Technology Scaling (OATS) method to assess the potential for abuse of a new abuse-deterrent formulation (ADF) of the opioid Remoxy, with 38 substance abuse counselors acting as proxies for opioid abusers.

Results indicated that the ADF showed significantly lower attractiveness for abuse compared to well-known opioids like OxyContin and Percocet, suggesting that this formulation may be a safer option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating attractiveness for abuse of a not-yet-marketed "abuse-deterrent" prescription opioid formulation. Butler, SF., Black, R., Grimes Serrano, JM., et al.[2013]

Naltrexone is a safe and effective treatment option for heroin dependence, particularly for highly motivated individuals who are already opiate-free.

While naltrexone has minimal side effects, primarily gastrointestinal issues, patient compliance remains a challenge due to the lack of immediate consequences for discontinuing the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of heroin-dependent persons with antagonists: current status. Renault, PF.[2013]

Citations

1.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34384

Efficacy of a password‐protected, pill‐dispensing device with ...

Among 30 patients enrolled, the majority (n = 24, 80%) returned the device, and 17 (57%) returned it within 6 weeks of surgery. In total, 567 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35819926/

Efficacy of a password-protected, pill-dispensing device ...

Results: Among 30 patients enrolled, the majority (n = 24, 80%) returned the device, and 17 (57%) returned it within 6 weeks of surgery. In ...

3.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/pdf/10.1002/cncr.34384

protected, pill‐ dispensing device with mail return capacity to ...

Furthermore, the detailed opioid use data generated by the smartphone app could help refine prescription guidelines. The system for pill use and ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06592378?cond=%22Fractures,%20Bone%22&aggFilters=status:not%20rec&rank=5

Study Details | NCT06592378 | Opioid Management for ...

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 ...

5.

researchgate.net

researchgate.net/publication/396285659_Improving_postoperative_opioid_stewardship_in_cancer-related_surgery_Impact_of_a_pill-dispensing_system_on_disposal_and_refill_rates

Impact of a pill-dispensing system on disposal and refill rates.

Secondary outcomes included opioid use, refills, pain control, and system usability, assessed through app data, EMRs, and patient surveys.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06358040

Opioid Dispenser for Microdiscectomy/Laminectomy

Addinex, a technology company, has developed a device to help patients take opioids more safely. In this study the investigators aim to enroll a total of 30 ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9705076/

Using Data Science to Improve Outcomes for Persons with ...

Nearly 500,000 people have died of an opioid overdose between 1999-2019, and initial estimates from 2020 suggest a 30% increase in overdose deaths during the ...