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Addinex Dispenser for Opioid Use Disorder

N/A
Recruiting
Research Sponsored by Addinex Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a new system (Addinex) helps people with opioid use disorder stay on their medication and reduce the risk of misuse. Results will show ease of use and user acceptance.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, generally Suboxone may cause dizziness, drowsiness, constipation, headache or mild withdrawal symptoms when adjusting doses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Drug Test for Opioid Use Disorder (Quest 12-Panel Drug Screen)
Secondary study objectives
PROMIS Self-Efficacy Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active - AppExperimental Treatment1 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: ControlActive Control1 Intervention
Patients in this arm will undergo standard at-home OUD treatment (n = 5/group) over 14-days.

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Who is running the clinical trial?

Addinex Technologies, Inc.Lead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Centers for Disease Control and PreventionFED
892 Previous Clinical Trials
22,000,752 Total Patients Enrolled
~7 spots leftby Jan 2026
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