Clinical trial NCT05859035: Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder
Official title: Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-Related Disorders
Lead sponsor: Biomedical Development Corporation
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-05-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Male or female outpatients 18 years of age or older
* Currently enrolled in an opioid treatment program and receiving medication assisted treatment 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 Criteria:

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

Primary outcomes:
measure: Usability Score
timeFrame: The Systems Usability Scale will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.
Secondary outcomes:
measure: User Satisfaction
timeFrame: A user satisfaction survey will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Jennifer Potter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: