NIH – Expanding the opioids system modeling efforts to more comprehensively address fentanyl, stimulants use, polysubstance use and associated outcomes. (U01) Clinical Trials Not Allowed

March 19, 2021 by


The purpose of this funding opportunity is to expand on the FDA’s modeling efforts to more comprehensively address fentanyl, stimulants and polysubstance use and their interactive effects on opioids use, misuse, use disorder, addiction treatment, and associated outcomes. The primary purpose of this project is to capture the dynamics of and interactions between stimulant or polysubstance use and opioid overdose deaths, as an important emerging aspect of the opioids crisis. The research should also seek to quantify how polysubstance use and synthetic opioids may influence the effects of harm reduction approaches and other potential overdose-prevention strategies. A secondary purpose of the research is to identify and implement feasible approaches for incorporating mental health into part of FDA’s modeling effort.


FDA’s opioids systems model is built upon academically rigorous standards and careful assessment of the best available evidence of the opioids system. FDA’s opioids systems model will be fully transparent and documented, as well as publicly available, for further reproducibility and validation. At its initial stage, the systems model is considered a “baseline” dynamic model limited in current scope and quantification.  The model has been developed to enable continual improvements, expansion, and adaptation as the complexities of the crisis change. There is a continual need to enhance the model by refining the underlying model structure, refining the quantification of the model parameters, expanding the scope as appropriate, and transforming the model into a practical policy analysis and communication tool.

Model development began internally in 2018. In September 2019, FDA awarded a grant under RFA-FD-19-026 to continue enhancing and improving FDA’s systems model mainly focusing on the following areas: 1- Enhance modeling of utilization, effectiveness, and outcomes of treatment for opioid use disorder (such as Medication-Assisted Treatment (MAT) and behavioral therapy); 2- Enhance modeling of opioids prescribing and prescription opioids utilization; 3- Research and enhance the modeling of potential interventions of most interest to FDA. In August 2020, FDA awarded a second grant under RFA-FD-20-031 to explicitly incorporate a) social outcomes (e.g. quality of life, untreated pain, and mental health and suicide) and b) cost and/or cost effectiveness of policy interventions to reduce or mitigate the negative impacts of the opioids crisis (e.g. FDA regulatory changes, development of new therapies, changing prescribing practices, increase adoption of opioids use disorder treatment approaches, and enhancement of prevention and harm reduction strategies) into FDA’s systems model and model analyses. RFA-FD-20-031 is anticipated to conclude in September 2021.

FDA has also awarded a two-year contract (September 2019 – September 2021). Key objectives of that contract include conducting a third-party review and validation of the model (as of October 2020) and supporting development of a policy tool and accompanying policy analysis service that can fit within FDA’s scientific and regulatory decision making processes. The current efforts are expected to result in a systems model and policy analysis tool to explore the intended and unintended consequences of potential opioids policy options.

Over the last two years, the collective efforts of the FDA and our collaborators have focused on model development and quantification. With the completion of an initial version of the model imminent, we are shifting focus to exploratory use of the model within FDA and incorporation of model enhancements. Our intent is to continue to enhance the model as the crisis – and our collective understanding of it – evolves. With opioid over dose death on the rise partly due to synthesized opioids and polysubstance use in the more recent years, one of the limitations of the current model is lack of in-depth consideration for complexities of the evolving opioids/stimulants crisis and policies that may address aspects of the crisis in terms of polysubstance use and harm reduction, as well as considerations for mental health comorbidities. We seek to fill this gap with this research.

Key Dates:

Open Date (Earliest Submission Date) – March 17, 2021
Letter of Intent Due Date(s) – April 5, 2021
Application Due Date(s) – May 17, 2021

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Filed Under: Funding Opportunities