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Active - App for Opioid Withdrawal Syndrome

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 four weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to four weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to four weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to four weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

PROMIS Self-Efficacy Scale

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Active - Text MessagingExperimental Treatment1 Intervention

Patients in this arm will undergo standard at-home OUD treatment in combination with the Addinex dispenser and texting (n = 20/group) over 30-days.

Group II: Active - AppExperimental Treatment1 Intervention

Patients in this arm will undergo standard at-home OUD treatment in combination with the Addinex dispenser and app (n = 20/group) over 30-days.

Group III: ControlActive Control1 Intervention

Patients in this arm will undergo standard at-home OUD treatment (n = 20/group) over 30-days.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Addinex Technologies, Inc.Lead Sponsor

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,342 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have enrolled in this research endeavor?

"Affirmative. Records on clinicaltrials.gov verify that this trial is actively enlisting participants, with the initial posting having been posted in February 24th 2023 and revised March 17th 2023. The study seeks 60 volunteers from a single medical centre."

Answered by AI

Is recruitment still accessible for this clinical trial?

"Per the information detailed on clinicaltrials.gov, this medical experiment is still seeking suitable participants. The trial was first advertised on 24th February 2023 and has since been modified on 17th March of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Suboxone Dispenser for OUD

2024. "Suboxone Dispenser for OUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05790551.