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Completed

NCT Number: NCT05412966

Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence

The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hassman Research Institute, LLC

Berlin, New Jersey, 08009, United States

About this study

The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O.

This feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process.

This study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provide written informed consent prior to any study specific assessments being performed
  • Male or female ≥18 years of age, inclusive
  • English proficiency to meaningfully participate in consent process, assessment and intervention
  • Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use)
  • Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment
  • Capable of using common software applications on an internet-enabled mobile device (smart phone or tablet)
  • Interested in testing or using PEAR-002b
  • No prior history of reSET-O use
  • Has not participated in any other investigational drug trials within the past 30 days (or within 5 half-lives of study drug, whichever is longer) of enrollment
  • Is considered appropriate for participation by their clinician

Exclusion criteria

  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy
  • DSM-5 diagnosis of OUD and already on buprenorphine
  • Planning to move out of the geographic area within 2 months
  • Unable to use English to participate in the consent process, the interventions, or assessments
  • Inability to comply with study procedures, due to severe medical conditions or otherwise
  • Currently receiving inpatient treatment for OUD
  • Women who are pregnant

Treatment and study plan

PEAR-002B

Device

PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder

reSET-O

Device

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

Primary outcomes

  1. PEAR-002B User Satisfaction Surveys

    Time frame: Week 1

    Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints

  2. PEAR-002B Qualitative User Experience Interviews

    Time frame: Week 1

    Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes

  3. Buprenorphine Initiation Success

    Time frame: Week 1

    Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit

  4. Medication Adherence Rates

    Time frame: From Week 1 to Week 4

    Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine

Secondary outcomes

  1. PEAR-002B Engagement Data

    Time frame: From Baseline to Week 1

    PEAR-002B engagement rates as measured by participant use patterns data

  2. reSET-O Qualitative User Experience Interviews

    Time frame: Week 4

    Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes

  3. reSET-O User Satisfaction Surveys

    Time frame: Week 4

    Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints

Other outcomes

  1. Abstinence From Illicit Opioids

    Time frame: From Baseline to Week4

    Abstinence from illicit opioid use as measured by urine immunoassay to detect the presence/absence of opioids.

  2. Treatment Retention

    Time frame: From Baseline to Week 4

    Treatment retention measured as time to drop out (last face to face contact with a patient) and analyzed using the Kaplan Meier method

  3. Device Wearing Time

    Time frame: From Baseline to Week 4

    Device wearing time as measured by EmbracePlus wearable device data

  4. Physiological Biomarker Data

    Time frame: From Baseline to Week 4

    Physiological data (e.g., heart rate) as measured by EmbracePlus wearable device

Sponsors and collaborators

Lead sponsor

Pear Therapeutics, Inc.

Industry

Collaborators

  • Hassman Research Institute, LLC
  • Kaiser Foundation Research Institute
  • National Institute on Drug Abuse (NIDA)
  • Whitman-Walker Institute, Inc.

Registry information

Official study title

A Feasibility Study of PEAR-002b, a Novel Prescription Digital Therapeutic to Support Unobserved Buprenorphine Initiation and Adherence in Opioid Use Disorder Outpatients

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2022
Registry last updated
Jan 9, 2023

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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