Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence
Completed · Not applicable
Conditions studied: Opioid Use Disorder
In brief
The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.
Key facts
- Study ID
- NCT05412966
- Run by
- Pear Therapeutics, Inc.
- People needed
- 7
- Starts
- 2022-11-04
- Expected to finish
- 2022-12-16
- Last updated by the study team
- 2023-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hassman Research Institute, LLC — Berlin, New Jersey, United States
Full record on ClinicalTrials.gov
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