LSD can heal crippling anxiety with just a single therapeutic dose

In a clinical trial by Mind Medicine Inc., a pioneering biopharmaceutical company, a single dose of LSD has shown promising results in providing immediate and sustained relief from generalized anxiety disorder. 

As a result of this successful trial, the United States Food and Drug Administration (FDA) has granted breakthrough therapy status to LSD formulation MM120 (lysergide d-tartrate).

This designation highlights LSD’s potential in addressing the urgent need for more effective options to treat anxiety. 

Breakthrough therapy status 

Dr. Daniel Karlin is an assistant professor of Psychiatry at Tufts University School of Medicine in Boston and chief medical officer for MindMed.

“A breakthrough designation is a recognition that a drug has demonstrated evidence of clinical efficacy in meeting an unmet medical need with morbidity and mortality associated with it,” said Dr. Karlin. 

The designation opens up enhanced collaborative opportunities with the FDA to streamline the drug development process. 

Clinical improvement among patients 

The clinical trial that spurred this designation focused on the efficacy of LSD in treating generalized anxiety disorder (GAD). 

Participants who received a single dose of MM120 exhibited a 48% rate of remission from GAD symptoms at the 12-week mark post-administration. In addition, 65% of patients showed marked clinical improvement within the first three months.

“The clinical improvement for many patients was more than double what we see with today’s standard of care,” said Dr. Karlin. “This occurred at all levels of anxiety, from moderate all the way up to severe.”

Optimal dose of LSD for treating anxiety

The trial was designed to pinpoint the optimal dosage of LSD needed to alleviate symptoms of generalized anxiety disorder. The experts tested varying amounts of MM120 ranging from 25 to 200 micrograms. 

The findings indicated that 100 micrograms is the ideal dose to advance into phase III studies, as higher doses did not enhance therapeutic outcomes and were associated with more adverse effects.

Unique approach to psychedelic therapy 

The research stands out not only for its promising results in GAD treatment but also because it diverges from the traditional approach of combining psychedelic therapy with psychotherapy. 

Unlike studies involving MDMA and psilocybin, where therapists play a crucial role during the drug administration process, the MM120 study did not incorporate psychotherapy. Instead, the trial included safety monitors who remained passive observers during the session.

Dr. Gabriella Gobbi, a professor at McGill University who was not involved in the study, highlighted the novelty of this approach. 

“While prior research has documented the benefits of combining LSD with psychotherapy to alleviate anxiety associated with life-threatening conditions, this groundbreaking study is the first to show that a single dose of LSD can effectively treat generalized anxiety without the adjunct of psychotherapy,” said Dr. Gobbi.

Breaking down negative thought processes with LSD

Professor David Nutt is the director of the Neuropsychopharmacology Unit at Imperial College London. He told CNN in an email that the study results are “very exciting data in what can be a difficult to treat population.”

“They expand the likely utility of psychedelic treatment beyond depression. And again, as with the depression trials, a single dose produces enduring effects, probable due to its breaking down persistent negative thought processes,” said Professor Nutt, who was not involved in the research.

According to Dr. Karlin, MM120 also improved signs of depression. “We saw rapid and robust improvement on depression symptoms in people – depression and anxiety have overlapping disease definitions.”

LSD formula reduces risk of adverse reactions 

The MM120 formulation’s quality is also a critical factor in its success. Unlike street-bought LSD, which can vary in purity and stability, MM120 is produced to pharmaceutical industry standards.

Compared with experiences with forms of LSD purchased illegally on the street, the study’s grade of MM120 did not appear to induce “bad trips,” noted Dr. Karlin.

“LSD is difficult to manufacture with high purity and tends to degrade quickly in the presence of light and water,” said Dr. Karlin. “We’re manufacturing it to pharmaceutical industry standards, a highly pure version that is also shelf stable. So that’s a critical difference.”

Adverse effects reported in the study were mostly mild to moderate and occurred primarily on the day of administration, including euphoria, illusions and hallucinations, and physical symptoms like nausea and dizziness.

Broader implications 

The FDA’s breakthrough therapy designation for MM120, alongside similar statuses for psilocybin and MDMA for other conditions, signifies a growing recognition of the therapeutic potential of psychedelics in treating psychiatric disorders. 

This development marks a significant milestone in the exploration of alternative treatment options for anxiety disorders. It inspires hope that soon, patients will have access to more effective and immediate relief from crippling symptoms of anxiety.

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