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| ID | Type | Description | Link |
|---|---|---|---|
| K01DA061975 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study aims to develop and evaluate dynamic treatment regimes (DTRs) to improve personalized care for individuals with opioid use disorder (OUD). Using machine learning methods and longitudinal data from a national behavioral health provider, the investigators will identify optimal treatment sequences that minimize the risk of overdose and improve recovery outcomes. A pilot hybrid factorial SMART trial will be conducted to assess the feasibility and acceptability of implementing these personalized treatment decision rules in real-world clinical settings.
This project supports the development and testing of dynamic treatment regimes (DTRs) for individuals with opioid use disorder (OUD), leveraging clinical and behavioral data from Discovery Behavioral Health and linked administrative records. In the first phase, multiple machine learning approaches (e.g., Q-learning, causal forests) will be used to estimate and validate DTRs that recommend tailored sequences of care based on patient characteristics and treatment response. The DTRs will be evaluated based on their ability to reduce fatal and non-fatal opioid overdose risk and hospital-based service use.
In the second phase, the investigators will conduct a pilot hybrid factorial Sequential Multiple Assignment Randomized Trial (SMART) to test the feasibility and acceptability of implementing the highest-performing DTR in a clinical setting. This pilot study will assess recruitment and retention, adherence to assigned treatment paths, and the practicality of integrating the DTR into routine care. The findings will inform a future full-scale trial aimed at improving personalized care for OUD and outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Intervention A + B | Experimental | Participants randomized to receive the combination of Intervention A and Intervention B in Week 1. Additional weekly interventions in Weeks 2-4 will be assigned based on participant response and dynamic treatment algorithms derived in Aim 1. |
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| Initial Intervention A + D | Experimental | Participants randomized to receive the combination of Intervention A and Intervention D in Week 1. Subsequent treatment assignments in Weeks 2-4 follow adaptive treatment decision rules. |
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| Initial Intervention C + B | Experimental | Participants randomized to receive the combination of Intervention C and Intervention B in Week 1. Adaptive treatment components are added weekly based on observed outcomes and predictive models. |
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| Initial Intervention C + D | Experimental | Participants randomized to receive the combination of Intervention C and Intervention D in Week 1. Participants receive additional interventions in Weeks 2-4 based on dynamic treatment regimes developed in the modeling phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication for opioid use disorder | Drug | A medication treatment component delivered in Week 1 as part of a 2×2 factorial SMART design. The exact content (e.g., treatment modality or intensity) will be finalized based on model results from Aim 1, which identifies optimal dynamic treatment regimes. |
| Measure | Description | Time Frame |
|---|---|---|
| CAT-SUD severity scores | Weekly Computerized Adaptive Test for Substance Use Disorder severity T-score. Scores range 0-100 (≈5-point precision). Higher scores indicate a greater SUD symptom burden/risk, while lower scores indicate fewer symptoms/lower risk. Prior validation studies have used <50 = low, 50-70 = intermediate, >70 = high severity/risk thresholds. Computerized Adaptive Test for Substance Use Disorder provides a dimensional severity score (not a diagnosis). Change is assessed week-to-week. | 4 weeks |
| Retention in treatment | Whether participants remained engaged in behavioral health treatment through the end of the 4-week study period. | 4 weeks |
| Patient and clinician satisfaction | Participant- and provider-reported satisfaction with the trial experience and procedures, assessed via standardized surveys. | 4 weeks |
| Clinical fidelity to intervention protoco | Fidelity of intervention delivery assessed via clinician checklists or independent fidelity ratings, evaluating adherence to protocol for each assigned treatment component. | Weekly over 4-week study period |
| Data completeness and consistency | Proportion of participants for whom ethical standards are fully maintained (e.g., informed consent obtained, no reported violations). Proportion of participants for whom ethical standards are fully maintained (e.g., informed consent obtained, no reported violations). Proportion of EHR and survey data points with missing or inconsistent entries. Thresholds for success include <5% missingness or inconsistency. | Throughout the 4-week trial |
| Timeliness of EHR data entry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason B Gibbons, PhD | Contact | 7734011266 | jbgibbons@bwh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discovery Behavioral Health | Irvine | California | 92612 | United States |
De-identified individual participant data (IPD) collected during the study, including survey responses, CAT-SUD scores, and treatment assignments, will be made available.
Beginning 1 year after study completion.
equests will be reviewed by the principal investigator. Data will be shared through a secure data use agreement upon IRB approval and execution of a data-sharing agreement.
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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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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D004191 | Behavioral Disciplines and Activities |
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The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design. Participants are initially randomized in a 2x2 factorial structure in Week 1 to receive one of four treatment combinations. In Weeks 2-4, additional weekly treatment components are assigned based on participant response and predefined decision rules. This structure allows for evaluation of dynamic treatment regimens tailored to individual needs and evolving treatment response.
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This is an open-label trial; no participants, providers, or investigators are masked to treatment assignment.
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| psychotherapy | Behavioral | A behavioral treatment component delivered in Week 1 as part of a 2×2 factorial SMART design. The exact content (e.g., treatment modality or intensity) will be finalized based on model results from Aim 1, which identifies optimal dynamic treatment regimes. |
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Proportion of EHR entries recorded within 48 hours of patient interaction. |
| Weekly throughout the 4-week trial |