Opioid Use Disorder
Conditions
Keywords
digital therapeutic
Brief summary
The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.
Detailed description
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.
Interventions
DEVICEPEAR-002B
PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder
DEVICEreSET-O
reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
Sponsors
Kaiser Foundation Research Institute
Whitman-Walker Institute, Inc.
National Institute on Drug Abuse (NIDA)
Hassman Research Institute, LLC
Pear Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent prior to any study specific assessments being performed 2. Male or female ≥18 years of age, inclusive 3. English proficiency to meaningfully participate in consent process, assessment and intervention 4. Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use) 5. Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment 6. Capable of using common software applications on an internet-enabled mobile device (smart phone or tablet) 7. Interested in testing or using PEAR-002b 8. No prior history of reSET-O use 9. 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 10. Is considered appropriate for participation by their clinician
Exclusion criteria
1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy 2. DSM-5 diagnosis of OUD and already on buprenorphine 3. Planning to move out of the geographic area within 2 months 4. Unable to use English to participate in the consent process, the interventions, or assessments 5. Inability to comply with study procedures, due to severe medical conditions or otherwise 6. Currently receiving inpatient treatment for OUD 7. Women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Rates | From Week 1 to Week 4 | Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine |
| PEAR-002B User Satisfaction Surveys | 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 |
| Buprenorphine Initiation Success | Week 1 | Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit |
| PEAR-002B Qualitative User Experience Interviews | Week 1 | Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reSET-O Qualitative User Experience Interviews | Week 4 | Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes |
| PEAR-002B Engagement Data | From Baseline to Week 1 | PEAR-002B engagement rates as measured by participant use patterns data |
| reSET-O User Satisfaction Surveys | 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
| Measure | Time frame | Description |
|---|---|---|
| Abstinence From Illicit Opioids | From Baseline to Week4 | Abstinence from illicit opioid use as measured by urine immunoassay to detect the presence/absence of opioids. |
| Physiological Biomarker Data | From Baseline to Week 4 | Physiological data (e.g., heart rate) as measured by EmbracePlus wearable device |
| Device Wearing Time | From Baseline to Week 4 | Device wearing time as measured by EmbracePlus wearable device data |
| Treatment Retention | 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 |
Countries
United States
Outcome results
None listed