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NCT Number: NCT07348796

Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD

The researchers will study the KIOS app, a digital health tool made to help people recovering from opioid addiction take better care of themselves. They want to see how the app works in real life and learn who benefits most from using it. The study will also ask participants what they think about the app and how easy it is to use.

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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

Participation in the study will last 12 months. Participants will be asked to complete assessments at 33 timepoints over the 12-month trial. This will include 1 screening assessment, 24 weekly assessments, 6 monthly assessments, and 2 follow-up assessments. All study assessments will be completed remotely.

Staff at each site will identify potential participants being treated with buprenorphine for opioid use disorder at their respective site. Providers will introduce the study and if interested, the participant will complete a screening assessment conducted by trained study staff to determine eligibility for the study.

Participants who are eligible will be enrolled into the study and given access to the KIOS app.

The active phase will include the first 6 months during which time participants will use the app, complete monthly assessments, and complete a weekly craving assessment. The second 6 months in the study will include two follow-up assessments at 9 months and 12 months post study start. At the end of the 12 months, app access will be removed. The follow up assessments will include the monthly assessments that were completed during the active phase, as well as the craving assessment. All assessments will be sent to the participants' email address for them to complete on any device with internet access. At the conclusion of 12 months of study participation, focus groups will be conducted with 25 of the participants to gather information about their perspectives on the app and its usability and features.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female outpatients 18 years of age or older
  • DSM-5 criteria for opioid use disorder
  • Ability to access KIOS via smartphone or tablet
  • Initiated buprenorphine treatment in the past 6 months

Exclusion criteria

  • Unwilling or unable to comply with study requirements
  • A psychiatric or medical condition interfering with ability to use the app
  • Incarceration
  • Suicide risk as determined by the treating medical clinician at the site

Treatment and study plan

KIOS App

Device

A digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS offers individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility.

Primary outcomes

  1. Retention in treatment

    Time frame: Baseline to 1 year

    The number of days from the start of the one-year intervention until the participant either leaves the trial or completes the trial.

Secondary outcomes

  1. Diagnostic Statistical Manual Version 5 (DSM-5)

    Time frame: Baseline to 12 months

    DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress

  2. Opioid Craving Scale

    Time frame: Baseline to 12 months

    A brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analog scale from 0-10. Items are as follows: 1) How much do you currently crave opiates?; 2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates?; and 3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today. The total scores range from 3-30 with a higher score indicating more opioid craving.

  3. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline to 12 months

    A self-administered 9-item depression module that scores each of the 9 DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition). Items are score 0 to 3, providing a 0 to 27 severity score. Scores of 5, 10, 15, and 20 represent cutoff points for mild, moderate, moderately severe, and severe depression, respectively.

  4. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline to 12 months

    The Generalized Anxiety Disorder-7 (GAD-7)13 measures anxiety with 7 items scored from 0 to 3, providing a 0 to 21 severity score. Scores of 5, 10, and 15 represent cutoff points for mild, moderate, and severe anxiety, espectively.

  5. Treatment Progress and Recovery (TEA)

    Time frame: 6 to 12 months

    The TEA gauges progress in treatment and recovery within four domains established by prior research: substance use, health (physical or emotional), lifestyle (housing/living situation, family, employment, relationships), and community (obeying laws, responsible member of society). For each area, the patient is asked to think about how much better things have become on a 10-point scale (1 = not better at all and 10 = very much better). Scores range between 0-40, with a higher score indicating greater progress in treatment and recovery

  6. System Usability Scale (SUS)

    Time frame: 6 months

    The System Usability Scale (SUS)15 is a 10-item measure for assessing a system's usability on a 5-point Likert scale from strongly agree to strongly disagree. Scores are converted to a 100-point scale. A score above a 68 would be considered above average usability.

  7. KIOS User Satisfaction Survey

    Time frame: 6 months

    Participants complete a survey specific to KIOS regarding: (1) the content, appropriateness, and relevance of the advice; (2) enhancement of self-management skills; (3) selfawareness; and (4) overall satisfaction with health. Survey items will be answered with level of agreement with a given statement recorded on a Likert-type 0 (Disagree) - 7 (Agree) scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Marino, PhD

CONTACT

[email protected]

(210) 567-5399

McKenna Garcia

CONTACT

[email protected]

(210) 450-7371

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

Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for Opioid Use Disorder (OUD)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 16, 2026
Registry last updated
Jul 23, 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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