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Behavioral Intervention

Active Treatment as Usual plus KIOS App for Opioid Use Disorder

N/A

Recruiting

Led By Jennifer Potter, PhD, MPH

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days to 12 weeks

Awards & highlights

Study Summary

This trial is comparing a mobile medical app called KIOS to the usual treatment for people with opioid use disorder.

Who is the study for?

This trial is for adults over 18 with opioid use disorder who can legally consent and communicate with the study team. Participants must have a smartphone or tablet to access the KIOS app and be recently enrolled in Medication-Assisted Treatment at a participating clinic. Those unable to follow study rules or with conditions that hinder app usage, as well as incarcerated individuals, cannot join.Check my eligibility

What is being tested?

The trial evaluates the effectiveness of the KIOS mobile medical app compared to standard treatment for opioid use disorder. It aims to see if using this educational app alongside usual care improves outcomes for patients managing their condition.See study design

What are the potential side effects?

Since this trial involves an educational mobile application rather than medication, traditional side effects are not expected. However, users may experience stress or frustration if they encounter technical difficulties or find the content challenging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can understand and communicate about the study, and I can legally consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days to 12 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

Percentage of Opioid Abstinent Days

Secondary outcome measures

Completion of treatment

Measure of opioid use reduction

Patient Health Questionnaire-9 (PHQ-9)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Treatment as Usual plus KIOS AppExperimental Treatment2 Interventions

Treatment as usual in clinics with the use of the KIOS App

Group II: Treatment as Usual plus KIOS education AppPlacebo Group2 Interventions

Treatment as usual in clinics with the use of the KIOs education App (Sham)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treatment as usual

2010

N/A

~6760

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,531 Total Patients Enrolled

Biomedical Development CorporationIndustry Sponsor

13 Previous Clinical Trials

683 Total Patients Enrolled

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,230 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies for participants in this clinical trial?

"Indeed, the current data on clinicaltrials.gov indicates that this trial is actively seeking participants. The initial posting date for the trial was February 1st, 2024, and it was last updated on January 8th, 2024. The study aims to enroll a total of 200 patients from a single site."

Answered by AI

What is the current number of participants involved in this clinical study?

"Indeed, the data available on clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking eligible participants. The trial was originally posted on February 1st, 2024 and had its most recent update on January 8th, 2024. A total of 200 individuals are being sought for participation in this study at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

KIOS Mobile App Evaluation

2024. "KIOS Mobile App Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06212557.

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