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

NCT07348796 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: STUDY000023084R44DA059017-02
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

KIOS app; Digital health; Real-world impact

Outcome Measures

Primary Outcomes (1)

• Retention in treatment

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

  Baseline to 1 year

Secondary Outcomes (7)

• Diagnostic Statistical Manual Version 5 (DSM-5)

  Baseline to 12 months

• Opioid Craving Scale

  Baseline to 12 months

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline to 12 months

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline to 12 months

• Treatment Progress and Recovery (TEA)

  6 to 12 months

Study Arms (1)

Treatment as usual and KIOS app

EXPERIMENTAL

Participants will be set up onto their preferred device(s) with assistance from a research assistant. KIOS will be accessible on all mobile devices as well as tablets. Treatment as usual (TAU) will be administered to all participants.

Device: KIOS App

Interventions

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.

Treatment as usual and KIOS app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Biomedical Development Corporation: collaborator

Study Sites (1)

University of Texas Health Science Center - Department of Psychiatry

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elise Marino, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Marino, PhD

CONTACT

(210) 567-5399; marinoe@uthscsa.edu

McKenna Garcia

CONTACT

(210) 450-7371; garciam98@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: One Arm open-label efficacy study

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 16, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

US (1)