Clinical trial NCT04542642: A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: digital therapeutic
Lead sponsor: Pear Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Addiction Research and Education Foundation (AREF)
name: Research Foundation for Mental Hygiene, Inc.
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-09-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Eligibility 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 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

Primary outcomes:
measure: Evaluate Participant Engagement Data
timeFrame: From Week 1 to Week 8 (End of Treatment)
Secondary outcomes:
measure: Evaluate Treatment Retention Based on Drop-Out Rates
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Evaluate Illicit Drug Abstinence
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Evaluate Digital Therapeutic Use Patterns Based on Usage Data
timeFrame: From Week 1 to Week 8 (End of Treatment)
measure: Assess Effect on Depressive Symptoms
timeFrame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Assess Effect on Anxiety Symptoms
timeFrame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Assess Effect on Recovery Capital
timeFrame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Describe Participant Satisfaction Surveys
timeFrame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Describe Participant Satisfaction Interviews
timeFrame: Week 12 (Follow-up)
measure: Assess Coronavirus Disease (COVID-19) Impact
timeFrame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Assess Coronavirus Disease (COVID-19) Impact on Stress
timeFrame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Assess Effect on Resilience
timeFrame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
Other outcomes:
measure: Evaluate Engagement and Efficacy Relationship
timeFrame: From Week 1 to Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Change in Skill Acquisition
timeFrame: Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up)
measure: Medication Adherence Rates
timeFrame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up)
Locations:
city: New York
country: United States
facility: The Substance and Treatment Research Service (STARS) at Columbia University Irving Medical Center and the New York State Psychiatric Institute
state: New York
city: Gig Harbor
country: United States
facility: Addiction Research and Education Foundation
state: Washington
Study officials:
affiliation: Columbia University
name: Aimee Campbell, PhD
role: STUDY_DIRECTOR
affiliation: Addiction Research and Education Foundation
name: Lisa Chiodo, PhD
role: STUDY_DIRECTOR
References:
citation: 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.