Suboxone Dispenser for OUD

NCT05790551 | Withdrawn FDA Device

• 1 other identifier: R43CE003533
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 system for doctors and patients?

Conditions

Opioid Use Disorder; Opioid Withdrawal

Outcome Measures

Primary Outcomes (1)

• Drug Test for Opioid Use Disorder (Quest 12-Panel Drug Screen)

  Urine analysis will be completed on a biweekly basis for the research study

  Up to two weeks

Secondary Outcomes (1)

• PROMIS Self-Efficacy Scale

  Up to two weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

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

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.

Device: Addinex

Interventions

Addinex DEVICE

Medication dispensing system for Suboxone

Active - App; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Addinex Technologies, Inc.: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Greenwich Hospital

Greenwich, Connecticut, 06830, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 30, 2023
• Study Start: January 15, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)