Addiction Neuromodulation Trials: How to Optimize Design and Outcomes

Wednesday, July 31, 2024 | 2 - 5 PM

Scope

This forum brings together professionals from academia, industry, NIH, and FDA to delve into the transformative potential of brain stimulation technologies for the treatment of substance use disorders. We will also discuss funding opportunities, quality standards and regulatory requirements. Join us for a dynamic three-hour session of insightful discussions and expert opinions. Following the forum, we invite you to unwind and connect during a casual meal and social gathering. Don't miss this opportunity to engage with thought leaders and expand your network in the field of addiction medicine.

Agenda Highlights

Gain insights from expert panel discussions on the latest advancements in addiction neuromodulation.
Learn about industry perspectives and how brain stimulation can be applied for addiction treatment.
Explore FDA regulatory perspectives on these innovative treatments.
Discuss new FDA approval and clearances and ongoing trials for addiction neuromodulation under FDA advisory.
Be informed on new NIDA funding opportunities for addiction neuromodulation.
Participate in a dynamic Q&A session to address your queries.
Enjoy valuable networking opportunities with professionals from various sectors.
Distinguished Speakers: This forum features renowned speakers from the industry, academia, NIH and FDA, providing diverse perspectives on the use of neuromodulation for addiction medicine.

Program

Time	Session
13:00-13:15	Where are we?
13:15-14:00	Granting and Regulatory Agencies FDA Requirements/Preferences: Robert Stefani, FDA NIDA Requirements/Preferences and Granting Opportunities: Will Aklin and John Fedota, NIDA NIH SBIR/STTR granting opportunities: Leonardo Angelone, NIDA and NIH MedTech Working with FDA to Design a Trial: Abhishek Datta, Soterix
14:00-16:00	Highlight Talks: How to Design and Report an RCT for Addiction Neuromodulation (5 min talks 3-4 slides): - Critical Path in Addiction Neuromodulation Clinical Trials: Hamed Ekhtiari - Clinical Considerations for Feasibility, Recruitment, and Safety in Conducting Addiction Neuromodulation Trials: Victor Tang, University of Toronto - Best Contextual Priming and Cue Exposure Protocol: Colleen Hanlon, Brainsway - How to Select a Consumption/Relapse Outcome Measure? Rita Goldstein, Mount Sinai - How to Select Craving or Other Subjective Outcome Measures? Claudia Padula, Stanford - The Integration of Composite Neurocognitive Endpoints in Addiction Neuromodulation Clinical Trials: Travis Baker, Rutgers University - How to Use Neuroimaging in Addiction Neuromodulation Trial, Potentials and Challenges: Tonisha Kearney-Ramos, Columbia University Medical Center - Individualization in Trials: Yes or No? Vaughn Steele, Yale University - How to Digitize a Trial: Andre Brunoni, USP, Brazil - Challenges and Hopes with Home Based tES Trials: Leigh Charvet, NYU - How to Optimize a Neuromodulatory Intervention: Michael Nitsche, Dortmund University - How to Boost Neuromodulation in Addiction: Kelvin Lim and Jazmin Camchong, UMN - How to Combine Interventions with Neuromodulation in a Trial, Bernard Le Foll, University of Toronto - Multi Centric Trials and FDA Standards, Abraham Zangen, Ben Gurion University of the Negev - Meta Analysis Requirements: Ghazaleh Soleimani, University of Minnesota - What I Learned from Running and Publishing an Addiction Neuromodulation Trial: Eduardo A. Garza-Villarreal - What I Learned from Running and Publishing an Addiction Neuromodulation Trial: Greg Sahlem, Stanford - What I Learned from Running and Publishing an Addiction Neuromodulation Trial: Tony P. George, University of Toronto - What I Learned from Running and Publishing an Addiction Neuromodulation Trial: Shirley Fecteau, Université Laval
16:00-16:45	Panel Discussion: What is Relevant and What is Not!
16:45-17:00	Where are we heading to?