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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Device: reSET-O
* Device: PEAR-008


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to receive either the game-based treatment (PEAR-008) or the original, FDA-authorized treatment (reSET-O).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: reSET-O<br>Prescription Digital therapeutic | Device: reSET-O<br>* reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.<br>|
| Experimental: PEAR-008<br>Investigational Digital Therapeutic | Device: PEAR-008<br>* PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Participant Engagement Data | Evaluate the number of active sessions per week between PEAR-008 and reSET-O | From Week 1 to Week 8 (End of Treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Treatment Retention Based on Drop-Out Rates | Evaluate if PEAR-008 increases retention in treatment compared to reSET-O by comparing drop-out rates | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up) | 
| Evaluate Illicit Drug Abstinence | Evaluate if PEAR-008 increases abstinence compared to reSET-O, as measured by saliva drug screens, urine drug screens and self-reporting | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up) | 
| Evaluate Digital Therapeutic Use Patterns Based on Usage Data | Evaluate participants' digital therapeutic use patterns based on usage data collected, comparing PEAR-008 to reSET-O | From Week 1 to Week 8 (End of Treatment) | 
| Assess Effect on Depressive Symptoms | Assess the effect of PEAR-008 and reSET-O on depressive symptoms using the eight-item Patient Health Questionnaire (PHQ-8) scores from Baseline to End of Treatment and Follow-up. The PHQ's total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) | 
| Assess Effect on Anxiety Symptoms | Assess the effect of PEAR-008 and reSET-O on anxiety symptoms using the Generalized Anxiety Disorder-7's (GAD-7) scores from Baseline to End of Treatment and Follow-up. The GAD-7's total score ranges from 0 (not clinically significant) to 21 (clinically significant) | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) | 
| Assess Effect on Recovery Capital | Assess the effect of PEAR-008 and reSET-O on recovery capital using the ten-item Brief Assessment of Recovery Capital (BARC-10) scores from Baseline to End of Treatment and Follow-up. The BARC-10's total score ranges from 10 to 60 | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) | 
| Describe Participant Satisfaction Surveys | Summarize participant satisfaction surveys and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) | 
| Describe Participant Satisfaction Interviews | Summarize participant satisfaction interviews and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics | Week 12 (Follow-up) | 
| Assess Coronavirus Disease (COVID-19) Impact | Assess the impact of the COVID-19 pandemic on participants using the five-item Council on American-Islamic Relations (CAIR) Pandemic Impact Questionnaire (C-PIQ) scores from Baseline to End of Treatment and Follow-up. The C-PIQ's total score ranges from 0 to 20 | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) | 
| Assess Coronavirus Disease (COVID-19) Impact on Stress | Assess the effect of the COVID-19 pandemic on depressive symptoms using the COPE: Coronavirus Perinatal Experiences - Impact Survey (COPE-IS) (MODIFIED) scores from Baseline to End of Treatment and Follow-up. Participants will be asked how they are coping with stress during COVID-19 from a list of responses. There is no scoring for this measure | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) | 
| Assess Effect on Resilience | Assess the effect of PEAR-008 and reSET-O on resilience using the 10-item Connor-Davidson Resilience Scale 10 (CD-RISC-10) scores from Baseline to End of Treatment and Follow-up. The CD-RISC-10 is a 10-item self-rating scale using a 5-point Likert scale ranging from not true at all to true nearly all of the time | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital therapeutic