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| ID | Type | Description | Link |
|---|---|---|---|
| R44DA042652 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Addiction Research and Education Foundation (AREF) | UNKNOWN |
| Research Foundation for Mental Hygiene, Inc. | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reSET-O | Active Comparator | Prescription Digital therapeutic |
|
| PEAR-008 | Experimental | Investigational Digital Therapeutic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reSET-O | Device | reSET-O is an FDA-authorized mobile application treatment for opioid use disorder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Treatment Retention Based on Drop-Out Rates | Evaluate if PEAR-008 increases retention in treatment compared to reSET-O by comparing 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Engagement and Efficacy Relationship | Evaluate the correlation between engagement (daily and weekly participant use patterns of PEAR-008 and reSET-O) and treatment outcomes (abstinence and retention in treatment) | From Week 1 to Week 8 (End of Treatment), Week 12 (Follow-up) |
| Change in Skill Acquisition |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aimee Campbell, PhD | Columbia University | Study Director |
| Lisa Chiodo, PhD | Addiction Research and Education Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35080499 | Derived | 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. |
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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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Participants will be randomly assigned to receive either the game-based treatment (PEAR-008) or the original, FDA-authorized treatment (reSET-O).
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Independent Outcomes Assessor will conduct data analysis and be blinded to intervention assignments.
| PEAR-008 | Device | PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder. |
|
Evaluate if PEAR-008 increases abstinence compared to reSET-O, as measured by saliva drug screens, urine drug screens and self-reporting |
| 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 | Evaluate participants' digital therapeutic use patterns based on usage data collected, comparing PEAR-008 to reSET-O | From Week 1 to Week 8 (End of Treatment) |
| Assess Effect on Depressive Symptoms | Assess the effect of PEAR-008 and reSET-O on depressive symptoms using the eight-item Patient Health Questionnaire (PHQ-8) scores from Baseline to End of Treatment and Follow-up. The PHQ's total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) |
| Assess Effect on Anxiety Symptoms | Assess the effect of PEAR-008 and reSET-O on anxiety symptoms using the Generalized Anxiety Disorder-7's (GAD-7) scores from Baseline to End of Treatment and Follow-up. The GAD-7's total score ranges from 0 (not clinically significant) to 21 (clinically significant) | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) |
| Assess Effect on Recovery Capital | Assess the effect of PEAR-008 and reSET-O on recovery capital using the ten-item Brief Assessment of Recovery Capital (BARC-10) scores from Baseline to End of Treatment and Follow-up. The BARC-10's total score ranges from 10 to 60 | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) |
| Describe Participant Satisfaction Surveys | Summarize participant satisfaction surveys and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) |
| Describe Participant Satisfaction Interviews | Summarize participant satisfaction interviews and evaluate if PEAR-008 increases participant satisfaction in treatment compared to reSET-O through descriptive statistics | Week 12 (Follow-up) |
| Assess Coronavirus Disease (COVID-19) Impact | Assess the impact of the COVID-19 pandemic on participants using the five-item Council on American-Islamic Relations (CAIR) Pandemic Impact Questionnaire (C-PIQ) scores from Baseline to End of Treatment and Follow-up. The C-PIQ's total score ranges from 0 to 20 | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) |
| Assess Coronavirus Disease (COVID-19) Impact on Stress | Assess the effect of the COVID-19 pandemic on depressive symptoms using the COPE: Coronavirus Perinatal Experiences - Impact Survey (COPE-IS) (MODIFIED) scores from Baseline to End of Treatment and Follow-up. Participants will be asked how they are coping with stress during COVID-19 from a list of responses. There is no scoring for this measure | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) |
| Assess Effect on Resilience | Assess the effect of PEAR-008 and reSET-O on resilience using the 10-item Connor-Davidson Resilience Scale 10 (CD-RISC-10) scores from Baseline to End of Treatment and Follow-up. The CD-RISC-10 is a 10-item self-rating scale using a 5-point Likert scale ranging from "not true at all" to "true nearly all of the time" | Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) |
Assess the effect of PEAR-008 and reSET-O on changes in skill acquisition using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ) from Baseline to End of Treatment. The CBTSQ measures two factors: Behavioral Activation (BA) and Cognitive Restructuring (CR). BA factor scores range from 0 to 35, and higher scores indicate greater use of BA skills. CR factor scores range from 0 to 45, and higher scores indicate greater use of CR skills |
| Baseline, Week 4, Week 8 (End of Treatment), Week 12 (Follow-up) |
| Medication Adherence Rates | Assess the effect of PEAR-008 and reSET-O on medication adherence rates using findings from saliva drug screens and urine drug screens | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8 (End of Treatment), Week 12 (Follow-up) |
| Addiction Research and Education Foundation | Gig Harbor | Washington | 98335 | United States |