KIOS Mobile App Evaluation

The University of Texas System (UT)

Status: Enrolling

Conditions: Opioid Use Disorder

Treatments: Device: KIOS App; Behavioral: Treatment as usual; Behavioral: KIOS App education

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06212557

R42DA054881 (U.S. NIH Grant/Contract)

HSC20210407H

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Active Treatment as Usual plus KIOS App

Experimental group

Description:

Treatment as usual in clinics with the use of the KIOS App

Treatment:

Behavioral: Treatment as usual

Device: KIOS App

Treatment as Usual plus KIOS education App

Sham Comparator group

Description:

Treatment as usual in clinics with the use of the KIOs education App (Sham)

Treatment:

Behavioral: KIOS App education

Behavioral: Treatment as usual