LSD could be approved for anxiety in the US in 2027 — SkimNews
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- Definium Therapeutics trial enrolled 200+ US adults with moderate-to-severe generalized anxiety disorder and found a single 100-microgram LSD dose cut anxiety by 9.8 points on a 56-point scale after three months, versus 4.7 points for placebo.
- Greg Cooper of University College London called it a "milestone" and said FDA approval is "fairly likely" within the next year or two, potentially setting a precedent for the UK and Europe.
- The trial excluded anyone with a history of psychosis or suicidal behavior; Cooper warned that LSD trips can last 6-12 hours and trigger intense fear or panic, urging against home use.
- Unlike most psychedelic trials, Definium gave participants only limited psychological support on dosing day rather than ongoing psychotherapy, deliberately testing the drug-only effect.
- To address the unblinding problem inherent to psychedelic research, the trial included a 50-microgram arm that produces mind-altering effects but didn't reduce anxiety in prior trials, functioning as an active placebo.
- Generalized anxiety disorder affects nearly 3% of US adults annually, and all trial participants had already failed multiple standard therapies before enrollment.
Why it matters: Generalized anxiety disorder affects nearly 3% of US adults annually with no new treatments in decades, so a single-dose LSD therapy showing a 9.8-point anxiety reduction would address a substantial unmet need. Demonstrating efficacy without bundled psychotherapy suggests a more scalable treatment model, but careful screening for psychosis history will be essential given LSD's 6-12 hour trip duration and rare but serious risks.
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