Psychedelic Drugs Are Rushing Towards Approval for Therapy. Here’s What’s Next

Psychedelic Drugs Are Rushing Towards Approval for Therapy. Here’s What’s Next

Yet one glaring problem remains. Despite promising clinical results, no one knows exactly how psychedelic drugs work in the brain. Examining their actions on brain cells isn’t just an academic curiosity. It could give rise to variants that maintain antidepressant properties without the high. And because hallucinogens substantially alter our perception [management?!] of the world, they could be powerful tools for investigating the neurobiology behind consciousness.

This year, scientists found another common themepsychedelics seem to “reset” the brain to a more youthful state, at least in mice. Like humans, mice have an adolescent critical period, during which their brains are highly malleable and can easily rewire neural circuits, but the window closes after adulthood.

An earlier study showed that MDMA reopens the critical window in adult mice, so that they change their “personality.” Mice raised alone are often introverted and prefer to keep to themselves in adulthood. A dose of MDMA increased their willingness to snuggle with other mice—essentially, they learned to associate socializing with happiness, concluded the study.

It’s not that surprising. MDMA is well-known to promote empathy and bonding. The new study, by the same team, extended their early results to four psychedelics that don’t trigger fuzzy feelings—LSD, ketamine, psilocybin, and ibogaine. Similar to MDMA, adult mice raised alone changed their usual preference for solitude when treated with any of the drugs. Because habits are hard to change in adulthood—for mice and men—the drugs may have reopened the critical period, allowing the brain to more easily rewire neural connections based on new experiences.

These are just early results. But psychedelic research is gaining a new ally—artificial intelligence. Algorithms that predict protein structure, combined with rational drug design, could generate psychedelics that retain their psychiatric benefits without the high.

H/T: The Most Revolutionary Act

Related:

Psychoanalytic roots of CIA psychoprofiling/pseudoscience

Meaghan thought psychedelic therapy could help her PTSD. Instead it was the start of a nightmare

Why is the American right suddenly so interested in psychedelic drugs

What if a Pill Can Change Your Politics or Religious Beliefs? (archived)

Do Psychedelic Trips Change Your Political Views? (archived)

New COVID Booster Approved From Final Study of Mice, Not Humans, But Using Only Animal Data Is a Needless Gamble

VERIFY: New COVID booster approved from final study of mice, not humans

According to documents on the CDC website, human tests of Moderna’s version of the new booster are still “ongoing.” Right now, there is only final evidence from “8-10 mice” per group.”

The FDA’s website shows for Pfizer the agency also relayed on the final study evidence from “8 mice.” But human trials are also ongoing. So far, the new boosters “showed a similar local reaction and systemic event profile.” That means side effects appear to be about the same including “mild to moderate injection site pain, fatigue, and muscle pain.”

“To advance the Omicron BA.4/BA.5 bivalent vaccine as rapidly as possible, regulators, including the FDA, WHO and EMA, have advised that our submissions be based on safety and immunogenicity data generated in adults with an Omicron BA.1 bivalent vaccine and supported by BA.4/BA.5 bivalent pre-clinical data and BA.4/BA.5 bivalent quality and manufacturing data. These packages follow a similar model to that provided to public health officials who evaluate seasonal flu vaccines each year. Moving forward, this approach may help address the pressing need for vaccines that provide a high level of protection against current and emerging variants of concern so that we can remain vigilant against this evolving virus. The FDA has authorized our Omicron BA.4/BA.5 bivalent vaccine based on clinical data generated in adults with an Omicron BA.1 bivalent vaccine, pre-clinical data with a BA.4/BA.5 bivalent vaccine and BA.4/BA.5 bivalent quality and manufacturing data. Pre-clinical data showed a booster dose of Pfizer and BioNTech’s Omicron BA.4/BA.5- bivalent vaccine generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. A clinical study investigating the safety, tolerability and immunogenicity of the Omicron BA.4/BA.5 bivalent vaccine in individuals 12 years of age and older is ongoing. Data will be shared with regulators when available. We are facing a virus with an exceptionally high mutation rate, which the nimble mRNA platform is well situated to address. Only the mRNA sequence requires updating to match emerging strains, and utilizing a bivalent vaccine aims to provide broader coverage against known and future COVID-19 variants of concern.”

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