Addinex Dispenser for Opioid Use Disorder

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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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?

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.

Is the Addinex Dispenser for Opioid Use Disorder safe for humans?

There is no specific safety data available for the Addinex Dispenser itself, but related treatments like naltrexone and buprenorphine have been found to be generally safe. Naltrexone has minimal side effects, mainly mild stomach issues, while buprenorphine is considered relatively safe with fewer severe side effects compared to other opioids. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Estimating attractiveness for abuse of a not-yet-marketed "abuse-deterrent" prescription opioid formulation. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Injectable and implantable sustained release naltrexone in the treatment of opioid addiction. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Buprenorphine exposures in adolescents and adults: a 10-year experience of a French Poison Control Center. [2021]