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

Pear Therapeutics, Inc.52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Opioid-use Disorder

Interventions

reSET-ODEVICE

reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.

PEAR-008DEVICE

PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

The Substance and Treatment Research Service (STARS) at Columbia University Irving Medical Center and the New York State Psychiatric Institute

New York, New York, United States

Addiction Research and Education Foundation

Gig Harbor, Washington, United States

Outcomes

Primary Outcomes

Evaluate Participant Engagement Data

Evaluate the number of active sessions per week between PEAR-008 and reSET-O

Time frame: From Week 1 to Week 8 (End of Treatment)

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.