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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Device: reSET-O; Device: PEAR-008

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • The Substance and Treatment Research Service (STARS) at Columbia University Irving Medical Center and the New York State Psychiatric Institute
  • Washington
    • Gig Harbor, Washington, United States, 98335
      • Addiction Research and Education Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Engagement and Efficacy Relationship	Evaluate the correlation between engagement (daily and weekly participant use patterns of PEAR-008 and reSET-O) and treatment outcomes (abstinence and retention in treatment)	From Week 1 to Week 8 (End of Treatment), Week 12 (Follow-up)
Change in Skill Acquisition	Assess the effect of PEAR-008 and reSET-O on changes in skill acquisition using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ) from Baseline to End of Treatment. The CBTSQ measures two factors: Behavioral Activation (BA) and Cognitive Restructuring (CR). BA factor scores range from 0 to 35, and higher scores indicate greater use of BA skills. CR factor scores range from 0 to 45, and higher scores indicate greater use of CR skills	Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
Medication Adherence Rates	Assess the effect of PEAR-008 and reSET-O on medication adherence rates using findings from saliva drug screens and urine drug screens	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)

Collaborators and Investigators

• Sponsor: Pear Therapeutics, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene, Inc.; Addiction Research and Education Foundation (AREF)
• Investigators: Study Director: Aimee Campbell, PhD, Columbia University; Study Director: Lisa Chiodo, PhD, Addiction Research and Education Foundation

Publications and helpful links

General Publications

• Luderer H, Chiodo L, Wilson A, Brezing C, Martinez S, Xiong X, Gerwien R, Imbert B, Deeg M, Maricich Y, Campbell A. Patient Engagement With a Game-Based Digital Therapeutic for the Treatment of Opioid Use Disorder: Protocol for a Randomized Controlled Open-Label, Decentralized Trial. JMIR Res Protoc. 2022 Jan 26;11(1):e32759. doi: 10.2196/32759.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): November 16, 2022
• Study Completion (Actual): November 23, 2022

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: digital therapeutic
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: PEAR-008-101; R44DA042652 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No