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Opioid-use DisorderNCT04542642

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

A study testing reSET-O and PEAR-008 in people with Opioid-use Disorder, run by Pear Therapeutics, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Opioid-use Disorder
What is being tested?
reSET-O and PEAR-008
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesUnited States
Study dates
19 May 2021to 23 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • On methadone or naltrexone pharmacotherapy
  • Unable to use English to participate in the consent process, interventions, or assessments
  • Inability to comply with study procedures

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Addiction Research and Education Foundation

    Gig Harbor, Washington, 98335

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

    New York, New York, 10019

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
reSET-O, PEAR-008
Keywords
digital therapeutic
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • reSET-ODevice

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

  • PEAR-008Device

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

Study groups in NCT04542642
Study groupRoleWhat they receive
reSET-OActive comparatorPrescription Digital therapeutic
Receives: Device: reSET-O
PEAR-008ExperimentalInvestigational Digital Therapeutic
Receives: Device: PEAR-008

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate Participant Engagement Data

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

    Measured: From Week 1 to Week 8 (End of Treatment)

Secondary outcomes (11)

  1. 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

    Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)

  2. 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

    Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)

  3. 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

    Measured: From Week 1 to Week 8 (End of Treatment)

  4. 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)

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

  5. 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)

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

  6. 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

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

  7. 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

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

  8. 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

    Measured: Week 12 (Follow-up)

  9. 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

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

  10. 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

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

  11. 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"

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start19 May 2021
  3. Primary completion16 Nov 2022
  4. Study completion23 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542642
Sponsor's protocol ID
PEAR-008-101
Other IDs
R44DA042652
Status last verified
Dec 2022
First submitted
27 Aug 2020
Last updated
14 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35080499

Questions about this trial

What is this clinical trial studying?

A study testing reSET-O and PEAR-008 in people with Opioid-use Disorder, run by Pear Therapeutics, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Participant Engagement Data (time frame: From Week 1 to Week 8 (End of Treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04542642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.

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