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



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

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

Study Design

Study Type
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized controlled 2 arm trial
Primary Purpose
Single (Investigator)
Masking Description
Randomization will be stratified by three characteristics: (1) buprenorphine or methadone, (2) history of MAT, and (3) stimulant use in past one month. Allocation to treatment groups will be randomly assigned by 1:1 allotment to either KIOS + TAU (treatment as usual) or KIOS sham + TAU with strata. Study staff will be blind to the condition to which the participant is assigned.

Arm Groups

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

Recruiting Locations

University of Texas Health Science Center - Department of Psychiatry
San Antonio, Texas 78229
Tara Wright, PhD, MS

More Details

The University of Texas Health Science Center at San Antonio

Study Contact

Jennifer Potter, PhD, MPH

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 information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.