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

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.

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.

Inclusion Criteria:

• Provide informed consent prior to any study specific assessments being performed
• Between 18 and 60 years old, inclusively
• Proficient in English language
• Within the first 120 days of starting buprenorphine treatment
• Receiving buprenorphine pharmacotherapy under the care of a licensed healthcare provider and willing to provide the provider or practice name
• Capable of using common software applications on a mobile device (smartphone)
• Access to an internet-enabled smartphone for the duration of the study, meeting minimal operations systems (OS) requirements
• Interest in using a digital therapeutic for Opioid-use Disorder
• No prior history of reSET-O use
• Has not participated in user testing of PEAR-008 or any investigational drug trials within the past 30 days of enrollment

Exclusion Criteria:

• On methadone or naltrexone pharmacotherapy
• Unable to use English to participate in the consent process, interventions, or assessments
• Inability to comply with study procedures