Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT07011758
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT07011758
Study Brief:
Protocol Section:
NCT07011758