Today is the second day of psychedelics @NIH ๐บ๐ฒ with a critical issue to be tackled:
What is a #controlled study with psychedelics?
How to do it?
Why is it important?
What is a #controlled study with psychedelics?
How to do it?
Why is it important?
Starting now with Michael Bogenschutz from @nyuniversity discussing what was left in the background yesterday: subjective effects 
Mixed correlation results between MEQ subjective ratings and therapeutic outcomes for alcohol abuse ๐ค
What now?
Is it all in the ๐ง ?
Is it all in the ๐ง ?
Now Jennifer Mitchell from @UCSF, first author of landmark Phase 3 MDMA for PTSD study out last year @NatureMedicine
Current PTSD standard of care
Drug OR psychotherapy?
Drug OR psychotherapy?
New model
Drug AND therapy?
Drug AND therapy?
In 2018 I explained why the new model can constitute a new paradigm frontiersin.org/articles/10.33โฆ
The essence of MDMA therapy
๐Love?โค๏ธ
๐Love?โค๏ธ
Useful method for double-blinding? ๐
Necessary? Sufficient?
Necessary? Sufficient?
SAEs, clearly higher in placebo arm
What about clinical equipoise and ethics for further trials?
What about clinical equipoise and ethics for further trials?
Efficacy ๐๐๐๐๐
Now @Drug_Researcher from @JHPsychedelics who's doing this for about 2 decades ๐ช mostly with #psilocybin
Is this even safe?
We can ask the ๐ฒ๐ฝMazatec๐ต as well
We can ask the ๐ฒ๐ฝMazatec๐ต as well
๐บ๐ฒDrug fatalities
๐พ๐ท๐บ๐ฌ๐
๐พ๐ท๐บ๐ฌ๐
Turn on, tune in, drop cigarettes? ๐ญ
Therapeutic effect?
Adverse effect?
Epiphenomena?
Adverse effect?
Epiphenomena?
Important considerations ๐ง
Now my dear friend and mentor Michael Mithoefer on his groundbreaking decades of work with MDMA therapy with @MAPS and @MAPSPBC
Blinding ๐challenges ๐
Low dose, a solution? ๐ค
Other comparators...
Phase 3 unblinding
Now discussant Elias Dakwar questioning the (in)famous P name(s)
Many models...
Watch out for epistemic injustices with those ""
Watch out for epistemic injustices with those ""
What's going on?
What's behind RCTs?
What can be lost?
Paradigm shift?
YES ๐
YES ๐
Ethics for new medicines.
Awesome discussion ๐๐ช๐๐๐
Awesome discussion ๐๐ช๐๐๐
Western culturally biased constructs
๐งจ
๐งจ
Another great panel, and a trully remarkable event!!! facing hard issues up-front ๐ช
Unblinding and controls clearly a difficult question.
Do we have a methodological problem, or do we have a philosophical issue?
tandfonline.com/doi/full/10.10โฆ
Do we have a methodological problem, or do we have a philosophical issue?
tandfonline.com/doi/full/10.10โฆ
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