A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic
- Conditions
- Opioid-use Disorder
- Interventions
- Device: PEAR-008Device: reSET-O
- Registration Number
- NCT04542642
- Lead Sponsor
- Pear Therapeutics, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEAR-008 PEAR-008 Investigational Digital Therapeutic reSET-O reSET-O Prescription Digital therapeutic
- Primary Outcome Measures
Name Time Method Evaluate Participant Engagement Data From Week 1 to Week 8 (End of Treatment) Evaluate the number of active sessions per week between PEAR-008 and reSET-O
- Secondary Outcome Measures
Name Time Method Evaluate Digital Therapeutic Use Patterns Based on Usage Data From Week 1 to Week 8 (End of Treatment) Evaluate participants' digital therapeutic use patterns based on usage data collected, comparing PEAR-008 to reSET-O
Evaluate Illicit Drug Abstinence Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up) Evaluate if PEAR-008 increases abstinence compared to reSET-O, as measured by saliva drug screens, urine drug screens and self-reporting
Assess Effect on Anxiety Symptoms Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) 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)
Describe Participant Satisfaction Surveys Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) Summarize participant satisfaction surveys and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics
Assess Coronavirus Disease (COVID-19) Impact Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) 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
Evaluate Treatment Retention Based on 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 if PEAR-008 increases retention in treatment compared to reSET-O by comparing drop-out rates
Describe Participant Satisfaction Interviews Week 12 (Follow-up) Summarize participant satisfaction interviews and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics
Assess Effect on Recovery Capital Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) 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
Assess Effect on Resilience Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) 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"
Assess Effect on Depressive Symptoms Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) 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)
Assess Coronavirus Disease (COVID-19) Impact on Stress Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) 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
Trial Locations
- 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