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

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04542642
• Other study ID #: PEAR-008-101
• Secondary ID: R44DA042652
• Status: Completed
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: November 23, 2022

Study information

• Verified date: December 2022
• Source: Pear Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 23, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Device:
• reSET-O
reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
• PEAR-008
PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Pear Therapeutics, Inc.	Addiction Research and Education Foundation (AREF), National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)