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Mind-altering substances are (still) falling short in clinical trials

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Why This Matters

These recent studies highlight the ongoing challenges in scientifically validating the efficacy of psychedelics like psilocybin for mental health treatment, emphasizing the difficulty of conducting unbiased clinical trials due to the drugs' perceptible effects. Despite the hype surrounding these substances, the results suggest that their therapeutic benefits may not be as clear-cut as previously thought, which could impact future research and regulatory decisions in the tech-driven health sector. For consumers and the industry, this underscores the importance of rigorous testing and cautious optimism when integrating emerging psychedelic therapies into mainstream medicine.

Key Takeaways

Two studies out earlier this week demonstrate just how difficult it is to study these drugs. And to my mind, they also show just how overhyped these substances have become.

To some in the field, the hype is not necessarily a bad thing. Let me explain.

The two new studies both focus on the effectiveness of psilocybin in treating depression. And they both attempt to account for one of the biggest challenges in trialing psychedelics: what scientists call “blinding.”

The best way to test the effectiveness of a new drug is to perform a randomized controlled trial. In these studies, some volunteers receive the drug while others get a placebo. For a fair comparison, the volunteers shouldn’t know whether they’re getting the drug or placebo.

That is almost impossible to do with psychedelics. Almost anyone can tell whether they’ve taken a dose of psilocybin or a dummy pill. The hallucinations are a dead giveaway. Still, the authors behind the two new studies have tried to overcome this challenge.

In one, a team based in Germany gave 144 volunteers with treatment-resistant depression either a high or low dose of psilocybin or an “active” placebo, which has its own physical (but not hallucinatory) effects, along with psychotherapy. In their trial, neither the volunteers nor the investigators knew who was getting the drug.

The volunteers who got psilocybin did show some improvement—but it was not significantly any better than the improvement experienced by those who took the placebo. And while those who took psilocybin did have a bigger reduction in their symptoms six weeks later, “the divergence between [the two results] renders the findings inconclusive,” the authors write.

Not great news so far.