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Completed

NCT Number: NCT06212557

KIOS Mobile App Evaluation

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

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center - Department of Psychiatry

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female outpatients 18 years of age or older
  • Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  • DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder
  • Ability to access KIOS via smartphone or tablet
  • Recently (less than 6 months) enrolled in and currently participating in MOUD at a clinic in Texas

Exclusion criteria

  • Unwilling or unable to comply with study requirements
  • Psychiatric or medical disorder interfering with ability to use the app
  • Incarceration

Treatment and study plan

KIOS App

Device

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

Other names: KIOS

KIOS App education

Behavioral

Educational tools provided to participants with opioid use disorder

Other names: KIOS education

Treatment as Usual

Behavioral

Behavioral counseling in clinic

Other names: TAU

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Completion of treatment

    Time frame: Baseline to 13 weeks

    Number of subjects that completed their participation in the study

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Biomedical Development Corporation
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Evaluation of KIOS in a 12-week Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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