Dynamic Treatment Regimes for Opioid Use Disorder

Официальное название

Dynamic Treatment Regimes for Personalized Opioid Use Disorder Care

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Medication for opioid use disorder
  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.
• Поведенческое psychotherapy
  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.

Первичные конечные точки

• CAT-SUD severity scores [Срок оценки: 4 weeks]
• Retention in treatment [Срок оценки: 4 weeks]
• Patient and clinician satisfaction [Срок оценки: 4 weeks]
• Clinical fidelity to intervention protoco [Срок оценки: Weekly over 4-week study period]
• Data completeness and consistency [Срок оценки: Throughout the 4-week trial]
• Timeliness of EHR data entry [Срок оценки: Weekly throughout the 4-week trial]

Критерии участия

Критерии включения

• Age 18 or older
• Diagnosed with opioid use disorder (OUD)
• Receiving care at a participating Discovery Behavioral Health site
• Able to provide informed consent

Критерии исключения

• Significant cognitive impairment or psychiatric instability that would prevent participation
• Current incarceration or involuntary commitment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Discovery Behavioral Health — Irvine

Идентификаторы

NCT: NCT07011758 · 2025p001360 · K01DA061975

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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