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| ID | Type | Description | Link |
|---|---|---|---|
| R44DA049493 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Foundation Research Institute | OTHER |
| Whitman-Walker Institute, Inc. | OTHER_GOV |
| National Institute on Drug Abuse (NIDA) | NIH |
| Hassman Research Institute, LLC |
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The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEAR-002B / reSET-O | Experimental | Digital Therapeutic |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEAR-002B | Device | PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| PEAR-002B User Satisfaction Surveys | 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 | Week 1 |
| PEAR-002B Qualitative User Experience Interviews | Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes | Week 1 |
| Buprenorphine Initiation Success | Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit | Week 1 |
| Medication Adherence Rates | Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine | From Week 1 to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| PEAR-002B Engagement Data | PEAR-002B engagement rates as measured by participant use patterns data | From Baseline to Week 1 |
| reSET-O Qualitative User Experience Interviews | Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence From Illicit Opioids | Abstinence from illicit opioid use as measured by urine immunoassay to detect the presence/absence of opioids. | From Baseline to Week4 |
| Treatment Retention | Treatment retention measured as time to drop out (last face to face contact with a patient) and analyzed using the Kaplan Meier method |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Hassman | Hassman Research Institute, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hassman Research Institute, LLC | Berlin | New Jersey | 08009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36662568 | Derived | Luderer H, Enman N, Gerwien R, Braun S, McStocker S, Xiong X, Koebele C, Cannon C, Glass J, Maricich Y. A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. JMIR Res Protoc. 2023 Jan 20;12:e43122. doi: 10.2196/43122. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| UNKNOWN |
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| reSET-O | Device | reSET-O is an FDA-authorized mobile application treatment for opioid use disorder. |
|
| Week 4 |
| reSET-O User Satisfaction Surveys | 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 | Week 4 |
| From Baseline to Week 4 |
| Device Wearing Time | Device wearing time as measured by EmbracePlus wearable device data | From Baseline to Week 4 |
| Physiological Biomarker Data | Physiological data (e.g., heart rate) as measured by EmbracePlus wearable device | From Baseline to Week 4 |