KIOS Mobile App Evaluation

April 1, 2026 updated by: The University of Texas Health Science Center at San Antonio

Evaluation of KIOS in a 12-week Randomized Controlled Trial

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center - Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 MOUD at a clinic in Texas

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Treatment as Usual plus KIOS App
Treatment as usual in clinics with the use of the KIOS App
Device: KIOS App
KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during Medication-Assisted Treatment (MAT)
Other Names:
  • KIOS
Behavioral: Treatment as usual
Behavioral counseling in clinic
Other Names:
  • TAU
Sham Comparator: Treatment as Usual plus KIOS education App
Treatment as usual in clinics with the use of the KIOs education App (Sham)
Behavioral: Treatment as usual
Behavioral counseling in clinic
Other Names:
  • TAU
Behavioral: KIOS App education
Educational tools provided to participants with opioid use disorder
Other Names:
  • KIOS education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in treatment
Time Frame: Baseline to 13 weeks
Measured by the number of days from the start of the 13-week intervention until the participant either leaves the trial, or completes the trial
Baseline to 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of opioid use reduction
Time Frame: 60 days to 13 weeks
Defined as abstaining from opioids during the last week and for at least 2 of the previous 3 weeks of the third month of MOUD treatment
60 days to 13 weeks
Percentage of Opioid Abstinent Days
Time Frame: Baseline to 13 weeks
Total abstinence, measured by urinalysis confirmed self-report of opioid use during the 13-week intervention
Baseline to 13 weeks
Completion of treatment
Time Frame: Baseline to 13 weeks
Number of subjects that completed their participation in the study
Baseline to 13 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline and 13 weeks
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 13 weeks
Treatment Effectiveness Assessment TEA)
Time Frame: Baseline and 13 weeks
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 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Institute on Drug Abuse (NIDA)
Biomedical Development Corporation

Investigators

  • Principal Investigator: Jennifer Potter, PhD, MPH, The University of Texas Health Science Center at San Antonio
  • Principal Investigator: Elise Marino, PhD, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Actual)

December 29, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20210407H
  • R42DA054881 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will be conducted in accordance with the following publication and data sharing policies and regulations:

National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.

IPD Sharing Time Frame

After study completion and data analysis when summary results are posted on ClinicalTrials.gov and then after peer review and publication acceptance.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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