Thread by @ee_schenberg

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…

@threadreaderapp compile please