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

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ClinicalTrials.gov Identifier: NCT04542642
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : February 1, 2021
Sponsor:
Collaborators:
Addiction Research and Education Foundation (AREF)
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Device: reSET-O Device: PEAR-008 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Independent Outcomes Assessor will conduct data analysis and be blinded to intervention assignments.
Primary Purpose: Treatment
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
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

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.




Primary Outcome Measures :
  1. Evaluate Participant Engagement Data [ Time Frame: 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 :
  1. Evaluate Treatment Retention Based on 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 if PEAR-008 increases retention in treatment compared to reSET-O by comparing drop-out rates

  2. Evaluate Illicit Drug Abstinence [ 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 if PEAR-008 increases abstinence compared to reSET-O, as measured by saliva drug screens, urine drug screens and self-reporting

  3. Evaluate Digital Therapeutic Use Patterns Based on Usage Data [ Time Frame: 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

  4. Assess Effect on Depressive Symptoms [ Time Frame: 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)

  5. Assess Effect on Anxiety Symptoms [ Time Frame: 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)

  6. Assess Effect on Recovery Capital [ Time Frame: 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

  7. Describe Participant Satisfaction Surveys [ Time Frame: Baseline, Week 4, Week 8 (End of Treatment) ]
    Summarize participant satisfaction surveys and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics

  8. Describe Participant Satisfaction Interviews [ Time Frame: 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

  9. Assess Coronavirus Disease (COVID-19) Impact [ Time Frame: 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

  10. Assess Coronavirus Disease (COVID-19) Impact on Stress [ Time Frame: 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

  11. Assess Effect on Resilience [ Time Frame: 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"


Other Outcome Measures:
  1. Evaluate Engagement and Efficacy Relationship [ Time Frame: From Week 1 to Week 8 (End of Treatment), Week 12 (Follow-up) ]
    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)

  2. Change in Skill Acquisition [ Time Frame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) ]
    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

  3. Medication Adherence 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) ]
    Assess the effect of PEAR-008 and reSET-O on medication adherence rates using findings from saliva drug screens and urine drug screens



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 60 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542642


Contacts
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Contact: Hilary Luderer 617-932-7504 hilary.luderer@peartherapeutics.com

Locations
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United States, New York
The Substance and Treatment Research Service (STARS) at Columbia University Irving Medical Center and the New York State Psychiatric Institute Recruiting
New York, New York, United States, 10019
Contact: Christina Brezing       christina.brezing@nyspi.columbia.edu   
United States, Washington
Addiction Research and Education Foundation Recruiting
Gig Harbor, Washington, United States, 98335
Contact: Angelo Cruz       acruz@addictionref.org   
Sponsors and Collaborators
Pear Therapeutics, Inc.
Addiction Research and Education Foundation (AREF)
Research Foundation for Mental Hygiene, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
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Study Director: Aimee Campbell, PhD Columbia University
Study Director: Lisa Chiodo, PhD Addiction Research and Education Foundation
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Responsible Party: Pear Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04542642    
Other Study ID Numbers: PEAR-008-101
R44DA042652 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
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.: No
Keywords provided by Pear Therapeutics, Inc.:
digital therapeutic
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders