Altered states: psychedelic, MDMA- and ketamine-assisted therapies
Evaluate the field’s most-publicised development on its actual evidence.
What you should be able to do afterwards
- 1Describe the three-phase protocol structure and why dosing is the smallest part
- 2Explain functional unblinding and why it matters so much here
- 3State the regulatory position accurately, including the FDA decision on MDMA
- 4Describe the specific ethical safeguards this field requires and why
The reading
This unit is an exercise in holding two things at once. The phase 3 MDMA results were among the largest reported for any PTSD treatment; the FDA declined approval in 2024 after an advisory committee voted against, citing unblinding, adverse-event reporting and misconduct at a trial site. Learning to describe both accurately, without becoming either an advocate or a debunker, is the skill.
What belongs to this unit
Questions to take away
For a seminar, a supervisor, or an argument with yourself.
- 1How would you design a psychedelic trial that solved the unblinding problem? Can it be solved?
- 2If the psychotherapy is inseparable from the drug, what is being approved?
- 3Who should have access to these treatments first, and who decides?