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

NCT04542642 | Completed DMC FDA Device

• 2 other identifiers: PEAR-008-101R44DA042652
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Opioid-use Disorder

Keywords

digital therapeutic

Outcome Measures

Primary Outcomes (1)

• Evaluate Participant Engagement Data

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

  From Week 1 to Week 8 (End of Treatment)

Secondary Outcomes (11)

• Evaluate Treatment Retention Based on Drop-Out Rates

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

• Evaluate Illicit Drug Abstinence

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

• Evaluate Digital Therapeutic Use Patterns Based on Usage Data

  From Week 1 to Week 8 (End of Treatment)

• Assess Effect on Depressive Symptoms

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

• Assess Effect on Anxiety Symptoms

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

Other Outcomes (3)

• Evaluate Engagement and Efficacy Relationship

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

• Change in Skill Acquisition

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

• Medication Adherence Rates

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

Study Arms (2)

reSET-O

ACTIVE COMPARATOR

Prescription Digital therapeutic

Device: reSET-O

PEAR-008

EXPERIMENTAL

Investigational Digital Therapeutic

Device: PEAR-008

Interventions

reSET-O DEVICE

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

reSET-O

PEAR-008 DEVICE

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

PEAR-008

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

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, United States

Location

Addiction Research and Education Foundation

Gig Harbor, Washington, 98335, United States

Location

Related Publications (1)

• 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.

  PMID: 35080499 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Aimee Campbell, PhD

  Columbia University

  STUDY DIRECTOR

• Lisa Chiodo, PhD

  Addiction Research and Education Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent Outcomes Assessor will conduct data analysis and be blinded to intervention assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to receive either the game-based treatment (PEAR-008) or the original, FDA-authorized treatment (reSET-O).

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: May 19, 2021
• Primary Completion: November 16, 2022
• Study Completion: November 23, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)