KIOS Mobile App Evaluation

Opioid Use Disorder Clinical Trial

Official title:

Evaluation of KIOS in a 12-week Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212557
• Other study ID #: HSC20210407H
• Secondary ID: R42DA054881
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Jennifer Potter, PhD, MPH
• Phone: 210-562-5698
• Email: potterjs[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).

Description:

The study is a parallel intervention examining the KIOS app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS will offer individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility. KIOS makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. KIOS gives patients 24/7 access to behavioral intervention strategies that can augment and improve response to routine clinic-based counseling interventions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female outpatients 18 years of age or older

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

3. DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder

4. ability to access KIOS via smartphone or tablet

5. Recently (less than 6 months) enrolled in and currently participating in MAT at a Be Well Texas (UT Health San Antonio) participating clinic

Exclusion Criteria:

1. Unwilling or unable to comply with study requirements

2. psychiatric or medical disorder interfering with ability to use the app

3. incarceration

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Device:
• KIOS App
KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during Medication-Assisted Treatment (MAT)

Behavioral:
• KIOS App education
Educational tools provided to participants with opioid use disorder
• Treatment as usual
Behavioral counseling in clinic

Locations

Country	Name	City	State
United States	University of Texas Health Science Center - Department of Psychiatry	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Biomedical Development Corporation, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Opioid Abstinent Days	Total abstinence, measured by urinalysis confirmed self-report of opioid use during the 12-week intervention	Baseline to 12 weeks
Secondary	Measure of opioid use reduction	Defined as abstaining from opioids during the last week and for at least 2 of the previous 3 weeks of the third month of MAT treatment	60 days to 12 weeks
Secondary	Retention in treatment	Measured by the number of days from the start of the 12-week intervention until the participant either leaves the trial, or completes the trial	Baseline to 12 weeks
Secondary	Completion of treatment	Number of subjects that completed their participation in the study	Baseline to 12 weeks
Secondary	Patient Health Questionnaire-9 (PHQ-9)	A 9 item questionnaire scored from 0 (Not at all) to 4 (Nearly every day) with a potential score of 0-36 with a lower score indicating better health and emotional well-being.	Baseline and 12 weeks
Secondary	Treatment Effectiveness Assessment TEA)	The TEA asks the participant to express the extent of changes for the better from your involvement in the program to this point (or how things are if it's your first TEA or baseline) in four areas: substance use, health, lifestyle, and community. For each area, think about how things have become better and circle the results on the scale below: the more you have improved, the higher the number -from 1 (not better at all) to 10 (very much better). Possible scores are between 1 and 40 with a lower score indicating a worse outcome.	Baseline and 12 weeks