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Completed

NCT Number: NCT04542642

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

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reSET-O

Device

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

PEAR-008

Device

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

Primary outcomes

  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 outcomes

  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), 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

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pear Therapeutics, Inc.

Industry

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2020
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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