Eduardo Schenberg, PhD Profile picture
Jan 13, 2022 โ€ข 36 tweets โ€ข 13 min read โ€ข Read on X
Today is the second day of psychedelics @NIH ๐Ÿ‡บ๐Ÿ‡ฒ 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 ๐Ÿค”
What now?

Is it all in the ๐Ÿง ?
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/10.33โ€ฆ
The essence of MDMA therapy

๐Ÿ’”Love?โค๏ธ
Useful method for double-blinding? ๐Ÿ™ˆ

Necessary? Sufficient?
SAEs, clearly higher in placebo arm

What about clinical equipoise and ethics for further trials?
Efficacy ๐Ÿ‘๐Ÿ‘๐Ÿ‘๐Ÿ‘๐Ÿ‘
Now @Drug_Researcher from @JHPsychedelics who's doing this for about 2 decades ๐Ÿ’ช mostly with #psilocybin
Is this even safe?

We can ask the ๐Ÿ‡ฒ๐Ÿ‡ฝMazatec๐ŸŒต as well
๐Ÿ‡บ๐Ÿ‡ฒDrug fatalities

๐Ÿพ๐Ÿท๐Ÿบ๐Ÿšฌ๐Ÿ“ˆ
Turn on, tune in, drop cigarettes? ๐Ÿšญ
Now @profceliamorgan from @UniofExeter ๐Ÿ‡ฌ๐Ÿ‡ง on Ketamine for alcohol ๐Ÿบ๐Ÿท๐Ÿพabuse
Therapeutic effect?

Adverse effect?

Epiphenomena?
Important considerations ๐Ÿง
Now my dear friend and mentor Michael Mithoefer on his groundbreaking decades of work with MDMA therapy with @MAPS and @MAPSPBC
Blinding ๐Ÿ™ˆchallenges ๐Ÿ™Š
Low dose, a solution? ๐Ÿค”
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 ๐Ÿ‘
Ethics for new medicines.

Awesome discussion ๐Ÿ‘๐Ÿ’ช๐Ÿ‘๐Ÿ‘๐Ÿ‘
Western culturally biased constructs
๐Ÿงจ
Another great panel, and a trully remarkable event!!! facing hard issues up-front ๐Ÿ’ช
Unblinding and controls clearly a difficult question.

Do we have a methodological problem, or do we have a philosophical issue?

tandfonline.com/doi/full/10.10โ€ฆ
@threadreaderapp compile please

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More from @ee_schenberg

Jun 6
Unblinding was the major issue in @Lykos_PBC MDMA efficacy review by @US_FDA's PDAC

In 2011 I started a post-doc with ayahuasca and figured out the obvious: double-blinding wouldn't work. In 2014 I discussed this at @Imperial_PRG without success

We need better epistemology ๐Ÿงต๐Ÿ‘‡ Image
It is striking how the field of evidence-based medicine (EBM) continuously endorses blinding as the most reliable control for post-randomization biases, when in fact there's much evidence to systemic failures and epistemic bias, as I presented at PS23 Image
Less than 10% of biomedical RCTs measure and report unblinding, and many unblinded trials were published without disclosing this issue, including in top journals and for already approved medications. Image
Read 26 tweets
Apr 11, 2023
7even years ago @PNASNews published results of our neuroimaging exploration with #LSD, bravely led daily by @RCarhartHarris and a young trio @LeorRoseman myself and @MendelKaelen in the early days of @Imperial_PRG, exploring unknown frontiers despite huge prejudice all around... Image
One day, with LSD inside my blood, I saw an unforgetable infinitude of things, including the MRI transform into a massive surgical robot laser-cutting thin slices of my brain which flew at light speed into the computer screen in the nearby room...
And I asked myself "Can they see my thoughts on screen"?

That seemed a silly idea and I laughed alone in the noisy cold room (relieved as other visions were of sensuous aesthetics, luckily never asked about ๐Ÿ™ƒ)...
Read 12 tweets
Mar 22, 2023
This equinox the @IPCC_CH released the updated edition of our best "manual for spaceship earth" ๐Ÿ˜‰, nicely summarized by Prof. @KHayhoe here:

Should we build connections between our existential #climatecrisis and psychedelics?
๐Ÿงต๐Ÿ‘‡ Image
In a nutshell:
"a batata ๐Ÿฅ” ta assando ๐Ÿ”ฅ"
(the potato is roasting), as people say in Brazil ๐Ÿ‡ง๐Ÿ‡ท when facing complicated problems Image
But the GOOD NEWS ๐Ÿคž is that YES we have many #AvailableSolutions ๐Ÿ’ซ

And as I highlighted in green in this image, indigenous lands and knowledge are fundamental for implementing some key solutions. Image
Read 12 tweets
Feb 16, 2023
This is likely the single most important paper in psychedelic science ๐Ÿ’ซ since "the LSD lid" (2017) and the "dmt-sigma 1" (2009) publications

What connects them is literally mind-blowing ๐Ÿคฏ
Absolutely congrats to @DEOlsonLab and all collaborators ๐Ÿ‘๐Ÿ‘๐Ÿ‘๐Ÿ‘๐Ÿ‘ science.org/doi/10.1126/scโ€ฆ
Here is the 2017 LSD "lid" paper by @zenbrainest et al, also superb cell.com/cell/fulltext/โ€ฆ
Read 4 tweets
Jan 14, 2022
This week #psychedelics, almost completely ignored by western science and medicine in the last quarter of the 20th century, made it to the top of ๐Ÿ‡บ๐Ÿ‡ธ healthcare, the @NIH:

4k folks ๐ŸŒ 21 time zones
+10h of talks
Panelists from
๐Ÿ‡บ๐Ÿ‡ธ 12
๐Ÿ‡จ๐Ÿ‡ฆ 1
๐Ÿ‡ฎ๐Ÿ‡ฑ 1
๐Ÿ‡ฉ๐Ÿ‡ฐ 1
๐Ÿ‡ฌ๐Ÿ‡ง 1
๐Ÿ‡ณ๐Ÿ‡ฟ 1
๐Ÿ‡จ๐Ÿ‡ญ 1

๐Ÿงต summary ๐Ÿ‘‡
Agenda comprised 3 main themes:
Basic and translational research ๐Ÿ€๐Ÿ”ฌ๐Ÿ‘ฉโ€๐Ÿ”ฌ๐Ÿ‘จโ€๐Ÿ”ฌ๐Ÿงฎ๐Ÿ’ป
Clinical trials ๐Ÿ‘ฉโ€โš•๏ธ๐Ÿง‘โ€โš•๏ธ๐Ÿ‘จโ€โš•๏ธ๐Ÿคฎ๐Ÿ’Š๐Ÿค’๐Ÿ’‰
Optimising future trial designs ๐Ÿ’พ๐Ÿ’ฝ๐Ÿ’ฟ๐Ÿ“€
Here are my remarks from 20y experience:
This is a good landmark to claim psychedelic science finally achieved maturity
Basic research is evolving rapidly and public funding ๐Ÿ’ฐis what is needed to transform the field
Clinical trials suggest transdiagnostic safety and efficacy
Read 5 tweets
Jan 13, 2022
Third and last session of #psychedelics @NIH ๐Ÿ‡บ๐Ÿ‡ฒ workshop starting now, looking at how to optimize clinical trials design and how to get these treatments approved ๐Ÿงต
Starting with Ido @hartogsohn ๐Ÿ‡ฎ๐Ÿ‡ฑ on psychedelic set and setting theory
Important Q โ“

Do we have an (excessively) costly and complicated drug regulation apparatus?
Read 19 tweets

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