Today is the second day of psychedelics @NIH 🇺🇲 with a critical issue to be tackled:
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 🤔
What now?
Is it all in the 🧠?
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?
New model
Drug AND therapy?
In 2018 I explained why the new model can constitute a new paradigm frontiersin.org/articles/10.33…
The essence of MDMA therapy
💔Love?❤️
Useful method for double-blinding? 🙈
Necessary? Sufficient?
SAEs, clearly higher in placebo arm
What about clinical equipoise and ethics for further trials?
Efficacy 👏👏👏👏👏
Now @Drug_Researcher from @JHPsychedelics who's doing this for about 2 decades 💪 mostly with #psilocybin
Is this even safe?
We can ask the 🇲🇽Mazatec🌵 as well
🇺🇲Drug fatalities
🍾🍷🍺🚬📈
Turn on, tune in, drop cigarettes? 🚭
Now @profceliamorgan from @UniofExeter 🇬🇧 on Ketamine for alcohol 🍺🍷🍾abuse
Therapeutic effect?
Adverse effect?
Epiphenomena?
Important considerations 🧐
Now my dear friend and mentor Michael Mithoefer on his groundbreaking decades of work with MDMA therapy with @MAPS and @MAPSPBC
Blinding 🙈challenges 🙊
Low dose, a solution? 🤔
Other comparators...
Phase 3 unblinding
Recent challenge at @NatureMedicine by @MattBurkeMD
Now discussant Elias Dakwar questioning the (in)famous P name(s)
Many models...
Watch out for epistemic injustices with those ""
What's going on?
What's behind RCTs?
What can be lost?
Paradigm shift?
YES 👍
Ethics for new medicines.
Awesome discussion 👍💪👏👏👏
Western culturally biased constructs
🧨
Another great panel, and a trully remarkable event!!! facing hard issues up-front 💪
Unblinding and controls clearly a difficult question.
Do we have a methodological problem, or do we have a philosophical issue?
tandfonline.com/doi/full/10.10…
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