Addiction Neuromodulation Trials: How to Optimize Design and Outcomes

This workshop was made possible with support from The Zabara Foundation and Soterix Medical

Wednesday, July 31, 2024 | 9 AM - 5 PM

Directors: Hamed Ekhtiari, MD, PhD; Colleen Hanlon, PhD

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
8 AM	Venue opens / Breakfast Served / Registration
8:30-9:00 AM	Greetings and opening
9:00-9:15 AM	Where are we in addiction neuromodulation? Hamed Ekhtiari, University of Minnesota
9:15-10:30 AM	Panel 1: Industry and Granting/ 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 - NIH Blueprint MedTech Working with FDA to Design a Trial: Abhishek Datta, Soterix Challenges in Addiction Neuromodulation Trials from the Industry Point of View: Colleen Hanlon, Brainsway Q&A and Panel Discussion
10:30-10:45 AM	Short Break
10:45 AM - 12:00 PM	Panel 2: Selection of Outcome Measures How to Select Craving or Other Patient Reported Outcome Measures for an Addiction Neuromod Trial? 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 Innovative Outcome Measures for an Addiction Neuromod Trial? Rita Goldstein, Mount Sinai Outcome Measures in NIDA Clinical Trial Network (CTN): Manish Jha, UT Southwestern Medical Center at Dallas Selection of Outcome Measures from the FDA Perspective, TBC Q&A and Panel Discussion
12:00-1:00 PM	Lunch Break (Lunch will be provided by the registration desk)
1:00-2:30 PM	Panel 3: Design and Reporting Challenges Clinical Considerations for Feasibility, Recruitment, and Safety in Conducting Addiction Neuromodulation Trials: Victor Tang, University of Toronto Best Contextual Priming and Cue Exposure Protocols: Colleen Hanlon, Brainsway Individualization in Trials: Yes or No? Vaughn Steele, Yale University How to Digitize a Trial: Andre Brunoni, USP, Brazil 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 Meta Analysis Reporting Requirements: Ghazaleh Soleimani, University of Minnesota Q&A and Panel Discussion
2:30-2:45 PM	Short Break
2:45-4:00 PM	Panel 4: Sharing Experiences from Previous Trials Multi Centric Trials and FDA Standards: Abraham Zangen, Ben Gurion University of the Negev Challenges of Running Home Based tES Trials: Leigh Charvet, NYU 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: Gregory 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 Addiction Neuromodulation Trials in NIDA Clinical Trial Network (CTN): Madhukar H. Trivedi and Manish Jha, UT Southwestern Medical Center at Dallas Q&A and Panel Discussion
4:00-4:45 PM	Forum Discussion: Harmonization in Addiction Neuromod Trials: What is Relevant and What is Not! Will Aklin, National Institute on Drug Abuse (NIDA) Marom Bikson, City University of New York Hamed Ekhtiari, University of Minnesota Colleen Hanlon, Wake Forest University
4:45-5:30 PM	Where are addiction neuromodulation trials heading to?
5:30-6:00 PM	Heading to the Conference Al Fresco Social Event
6:00-7:30 PM	Social Event at Baylander Steel Beach - West Harlem Piers