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Development of a Sham Smartphone App for Opioid Use Disorder: Acceptability and Suitability Study.
Kierstyn S Gallegos1, Jennifer S Potter1,2, Van L King1,2
1Be Well Institute on Substance Use and Related Disorders, University of Texas Health Science Center at San Antonio, 5109 Medical Drive, San Antonio, TX, 78229, United States, 1 210 450 3760.
JMIR Formative Research
|August 8, 2025
Summary
A sham app for opioid use disorder (OUD) treatment was developed and tested. The app proved suitable as a control, with most participants believing it was active and reporting high satisfaction, validating its use in clinical trials.
Area of Science:
- Digital Therapeutics
- Behavioral Health
- Clinical Trial Methodology
Background:
- Opioid use disorder (OUD) treatment faces challenges with patient dropout despite evidence-based medications.
- Prescription digital therapeutics offer potential to improve OUD treatment adherence and retention.
- Utilizing a sham app in randomized clinical trials is an innovative approach to assess true digital therapeutic efficacy.
Purpose of the Study:
- To develop and evaluate a sham smartphone application for use as a control in opioid use disorder (OUD) treatment research.
- To determine the suitability of the sham app as a placebo control by assessing participant perception and lack of clinical effect.
Main Methods:
- A 4-week trial involving 21 participants to test a sham smartphone app for OUD.
- Suitability criteria included participants believing the app was active and showing no clinical improvement in depression or quality of life.
- Data collection involved pre- and post-intervention assessments, user satisfaction surveys, and semistructured interviews analyzed qualitatively.
Main Results:
- The sham app met suitability criteria: 95% of participants believed it was an active intervention, and no significant clinical improvements were observed.
- High user satisfaction (91%) was reported, with qualitative themes including perceived value, behavior change potential, and usability.
- Participant engagement showed an average of 17.8 log-ins, with 71% meeting the goal of 3 weekly log-ins.
Conclusions:
- The developed sham app is suitable for use as a control condition in randomized clinical trials for digital therapeutics targeting OUD.
- This validated sham app enhances the rigor of clinical trials, ensuring accurate assessment of prescription digital therapeutic efficacy.
- The findings support the use of well-designed sham digital therapeutics to rigorously evaluate novel app-based interventions.
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