NCT04542642

A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic

A Randomized, Controlled, Open-Label, Decentralized Study, to Evaluate Patient Engagement With PEAR-008, a Game-Based Digital Therapeutic for the Treatment of Opioid Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Pear Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how patients use and engage with a game-based mobile application that is designed to treat opioid use disorder.

Detailed description

This is a randomized, controlled, open-label, decentralized study to evaluate patient engagement with PEAR-008, a game-based digital therapeutic for the treatment of opioid use disorder. PEAR-008 is a new version of reSET-O, an FDA-authorized mobile application treatment (available by prescription only) for opioid use disorder. The study will examine if changing the application's delivery format and enhancing clinical content affects how patients use and interact with the intervention. Prospective participants will complete a short screening assessment and if eligible complete informed consent procedures at the beginning of the Baseline visit. Qualifying participants will attend weekly virtual study visits during the 8-week treatment period. In addition to weekly assessments, additional assessments will be administered at week 4 and week 8. Participants will be asked to complete a follow-up assessment 4 weeks after completing treatment.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DEVICE	reSET-O	reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
DEVICE	PEAR-008	PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.

Timeline

• Start date: 2021-05-19
• Primary completion: 2022-11-16
• Completion: 2022-11-23
• First posted: 2020-09-09
• Last updated: 2022-12-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study