Dr. Linda Strauss, biochemist and clinical trial expert at EI Ventures, discusses the inclusion and exclusion criteria of clinical trials investigating psychedelic medicines like psilocybin.
Insight
Psilocybin breaks neural connections so follow-on psychotherapy can rewire them
“So if you think about a psychedelic trip, you can imagine that the psilocybin breaks apart those neural connections and then follow on psychotherapy Will reconnect them in a, air quote, healthier way.”
Prediction Open · timeframe Apr 2027
The FDA will not approve psychedelic medicines without accompanying talk therapy
“I don't see the FDA, by the way, Sean, a hundred percent. I don't see the FDA approving any of this that isn't in combination with some form of talk therapy.”
Assertion Not checkable as stated
Psychedelics are pursuing FDA clinical pathways much more than cannabis did
“I see A lot more activity on the regulated pathway, whereas cannabis has clearly taken the adult use pathway with very few products that have moved into that space with Epidiolex being the exception to the rule.”
Assertion Supported
Serious psilocybin side effects are linked to 5-HT receptor binding
“Now there is some side effects, serious side effects that have emerged with psilocybin due to its binding to the five HT The two B receptor. It's either the two A receptor, the two B receptor.”
Assertion Supported
Areas with cannabis dispensaries see lower rates of opioid use disorder
“There's a great study, I want to say it's out of UC Davis, that's literally shown a slightly different crisis, but the opioid overuse, you know, substance abuse diseases, an opioid use that's shown that in areas where there's cannabis dispensaries, there's a l…”
Disclosure
EI Ventures is developing a transdermal delivery patch for psilocybin
“In a press release, it's publicly announced that we are, at EI Ventures, are working with a contract research organization to develop a transdermal psilocybin patch, ultimately.”