Optimizing Addiction Medicine RCTs in the Developing World

Randomized controlled trials (RCTs) are the gold standard for testing the safety and comparative effectiveness of treatments for substance use disorders (SUDs). Yet, many regions of the developing world—as well as minoritized communities in North America and Europe—are underrepresented in large, multi-centre RCTs in addiction medicine. Given these limitations, we bring together leading global experts in comparative effectiveness research to discuss innovations for optimizing RCT development in addiction medicine.

Co-chairs: Drs. Kevin Xu (Washington University in St. Louis, USA) and Vitor Tardelli (UNODC, Austria)

1) Dr. Vitor Tardelli and Dr. Thiago Fidalgo (Universidade Federal de São Paulo, Brazil) are leaders in global efforts to design RCTs for stimulant use disorders. Dr. Tardelli will discuss how to choose outcomes for clinical trials on stimulant use disorders. Dr. Fidalgo will present best practices for picking efficacy outcomes and mitigating attrition.

2) Dr. Adam Bisaga (Columbia University, USA) has received funding from NIDA for over 25 years to conduct randomized controlled trials on novel pharmacotherapies for addiction. He also serves as a member of the UN Office on Drugs and Crime (UNODC) Expert Panel and acts as a consultant for the WHO. He will discuss actionable strategies to address the challenges in developing RCTs in addiction medicine.

3) Dr. Alireza Noroozi (Iranian National Center for Addiction Studies, Iran) is an expert on the pilot testing of behavioral interventions of SUDs in Iran and Afghanistan. He will discuss cultural adaptation of evidence-based behavioral treatments for SUDs into Afghanistan.

4)Finally, Dr. Xu, a pharmaco-epidemiologist, will discuss trending approaches to address limitations of RCTs , including target trial emulation (a framework for applying RCT principles to emulate trials using observational data). Drs. Tardelli and Xu will subsequently lead a discussion among speakers and the audience.