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

Primary Purpose

Opioid-use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

reSET-O

PEAR-008

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring digital therapeutic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

reSET-O

PEAR-008

Arm Description

Prescription Digital therapeutic

Investigational Digital Therapeutic

Outcomes

Primary Outcome Measures

Evaluate Participant Engagement Data

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

Secondary Outcome Measures

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

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

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

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)

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)

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

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

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

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

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

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"

Full Information

NCT ID

NCT04542642

First Posted

August 27, 2020

Last Updated

December 13, 2022

Sponsor

Pear Therapeutics, Inc.

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04542642

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

May 19, 2021 (Actual)

Primary Completion Date

November 16, 2022 (Actual)

Study Completion Date

November 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pear Therapeutics, Inc.

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-use Disorder

Keywords

digital therapeutic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Masking Description

Independent Outcomes Assessor will conduct data analysis and be blinded to intervention assignments.

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

reSET-O

Arm Type

Active Comparator

Arm Description

Prescription Digital therapeutic

Arm Title

PEAR-008

Arm Type

Experimental

Arm Description

Investigational Digital Therapeutic

Intervention Type

Device

Intervention Name(s)

reSET-O

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PEAR-008

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluate Participant Engagement Data

Description

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 Outcome Measure Information:

Title

Evaluate Treatment Retention Based on Drop-Out Rates

Description

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)

Title

Evaluate Illicit Drug Abstinence

Description

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)

Title

Evaluate Digital Therapeutic Use Patterns Based on Usage Data

Description

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)

Title

Assess Effect on Depressive Symptoms

Description

Time Frame

Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)

Title

Assess Effect on Anxiety Symptoms

Description

Time Frame

Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)

Title

Assess Effect on Recovery Capital

Description

Time Frame

Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)

Title

Describe Participant Satisfaction Surveys

Description

Summarize participant satisfaction surveys and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics

Time Frame

Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)

Title

Describe Participant Satisfaction Interviews

Description

Summarize participant satisfaction interviews and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics

Time Frame

Week 12 (Follow-up)

Title

Assess Coronavirus Disease (COVID-19) Impact

Description

Time Frame

Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)

Title

Assess Coronavirus Disease (COVID-19) Impact on Stress

Description

Time Frame

Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)

Title

Assess Effect on Resilience

Description

Time Frame

Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)

Other Pre-specified Outcome Measures:

Title

Evaluate Engagement and Efficacy Relationship

Description

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)

Time Frame

From Week 1 to Week 8 (End of Treatment), Week 12 (Follow-up)

Title

Change in Skill Acquisition

Description

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

Time Frame

Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)

Title

Medication Adherence Rates

Description

Assess the effect of PEAR-008 and reSET-O on medication adherence rates using findings from saliva drug screens and urine drug screens

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aimee Campbell, PhD

Organizational Affiliation

Columbia University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Lisa Chiodo, PhD

Organizational Affiliation

Addiction Research and Education Foundation

Official's Role

Study Director

Facility Information:

Facility Name

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

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Addiction Research and Education Foundation

City

Gig Harbor

State/Province

Washington

ZIP/Postal Code

98335

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35080499

Citation

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.

Results Reference

derived

Learn more about this trial

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

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