Can neuroimaging save psychedelic drug development?

Neuroimaging (mostly with functional Magnetic Resonance Imaging; fMRI) has been a keystone method of modern psychedelic research and has provided fundamental data informing our current understanding of psychedelic drug action. My thesis in this talk is that neuroimaging methods can now form a vital part of the strategy as we seek to transition psychedelic-based therapies to regulated and licensed status. First, research aimed at establishing the detailed brain mechanisms of how psychedelic therapies produce their clinical effects will help to reassure regulators of their effectiveness. Second, the use of objective (brain-based) markers of psychedelic effects can help to mitigate and neutralize concerns around expectancy and placebo effects. Third, brain-based effects can help to validate novel dosing regimes (e.g. micro/midi-dosing) or administration routes. Fourth, identification of (putative) prospective biomarkers of treatment response may improve psychedelic clinical trials by enabling patient stratification. Fifth, second generation/derivative compounds are essentially novel drugs and will need to be characterized as such, ideally by use of combined molecular and functional imaging. Neuroimaging and brain-based measures of action will therefore continue to serve a vital and increasingly prominent role in modern psychedelic science and drug development.