Clinical trial NCT06212557: KIOS Mobile App Evaluation
Official title: Evaluation of KIOS in a 12-week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Digital health therapeutic
Behavioral intervention strategies
Clinic-based counseling
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Biomedical Development Corporation
First posted: 2024-01-19
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled 2 arm trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention in treatment
timeFrame: Baseline to 13 weeks
Secondary outcomes:
measure: Measure of opioid use reduction
timeFrame: 60 days to 13 weeks
measure: Percentage of Opioid Abstinent Days
timeFrame: Baseline to 13 weeks
measure: Completion of treatment
timeFrame: Baseline to 13 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 13 weeks
measure: Treatment Effectiveness Assessment TEA)
timeFrame: Baseline and 13 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center - Department of Psychiatry
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Jennifer Potter, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Elise Marino, PhD
role: PRINCIPAL_INVESTIGATOR
References: