NCT06212557

KIOS Mobile App Evaluation

Evaluation of KIOS in a 12-week Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DEVICE	KIOS App	KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during Medication-Assisted Treatment (MAT)
BEHAVIORAL	KIOS App education	Educational tools provided to participants with opioid use disorder
BEHAVIORAL	Treatment as usual	Behavioral counseling in clinic

Timeline

• Start date: 2024-05-02
• Primary completion: 2025-12-29
• Completion: 2026-05-31
• First posted: 2024-01-19
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study