Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder

Last updated: December 15, 2023
Sponsor: Biomedical Development Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Treatment

KIOS Informational App

Clinical Study ID

NCT05859035
23-0232H
R42DA054881
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. This study is designed to test the prototype app, not to determine health outcomes. The study will confirm the design and operating specifications prior to being evaluated in a larger clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female outpatients 18 years of age or older
  • Currently enrolled in an opioid treatment program and receiving medication assistedtreatment for opioid use disorder
  • Currently stable in opioid use disorder outpatient treatment for 4 weeks or longer
  • Ability to access the app via smart phone, or tablet.

Exclusion

Exclusion Criteria:

  • Unwilling or unable to comply with study requirements
  • Have a psychiatric or medical disorder interfering with ability to use the app
  • Incarcerated
  • Pregnant

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: KIOS Informational App
Phase:
Study Start date:
June 29, 2023
Estimated Completion Date:
January 10, 2024

Study Description

The overall study is designed in two steps: 1) a one-week proof-of-concept study; and 2) a one-month pilot study.

Step 1: A one-week proof-of-concept study will be performed in a small population (n=5) of individuals in opioid use disorder recovery as an indicator of the app's suitability. Study participants will use the sham app for one week and will then complete a usability and user satisfaction survey. If the app is found to be exhibit acceptable usability and satisfaction, a one month study will be completed in a larger sample (see Step 2, below). If not, modifications to the app will be made and the one-week study will be repeated in a new group of participants.

Step 2: After completion of the proof-of-concept study, 20 new participants will be enrolled in a 4-week trial. Study participants will complete baseline assessments and then be asked to use the app at least three times per week, for four weeks. At the end of four weeks, participants will complete usability and user satisfaction surveys.

Connect with a study center

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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