Single dose of LSD provides immediate, long-lasting relief from anxiety, study finds

Encouraging results from a clinical trial have granted the U.S. Food and Drug Administration breakthrough therapy status for a formulation of LSD to treat generalized anxiety disorder, Mind Medicine Inc. announced Thursday. The biopharmaceutical company is developing the drug.

“A breakthrough designation is the recognition that a drug has demonstrated evidence of clinical effectiveness in meeting an unmet medical need with associated morbidity and mortality,” said Dr. Daniel Karlin, assistant professor of psychiatry at the University School of Medicine. from Tufts in Boston and Medical Director of MindMed.

MindMed’s MM120 will continue to go through the standard FDA approval process, including Phase III trials.

The designation, however, “is an offer by the agency to be more closely involved in drug development,” Karlin said. “It impacts response times and our ability to get more interactions with the agency so we can be sure we’re on an agreement as we move forward.”

Two other companies have also received breakthrough therapy status from the FDA: psilocybin for treatment-resistant depression and MDMA (3,4-methylenedioxymethamphetamine), commonly known as ecstasy or molly, for post-traumatic stress disorder. posttraumatic stress.

New results on efficacy at 12 weeks

According to MindMed, a single dose of MM120 (lysergide d-tartrate) produced a 48 percent remission rate of generalized anxiety disorder 12 weeks after administration of the drug.

The drug MM120 also significantly improved clinical signs of generalized anxiety disorder in 65 percent of patients within three months, based on results from the Phase 2b trial designed to test dosage levels, the company said.

Anxiety is the most common mental disorder in the United States, affecting more than 40 million people over the age of 18 each year, according to the American Anxiety and Depression Association. The order of generalized anxiety is characterized by excessive and continuous thoughts that are difficult to control and interfere with day-to-day activities.

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

The standard of care for generalized anxiety disorder is a combination of cognitive behavioral therapy and medications such as selective serotonin reuptake inhibitors (SSRIs) and buspirone (both act on serotonin levels in the brain), as well as sedatives called benzodiazepines.

All of these medications take time to work and may require experimentation with various doses, which adds time and expense to patient treatment, Karlin said.

Determine the proper dosage

The multicenter, randomized, double-blind trial tested doses of 25, 50, 100 and 200 micrograms compared to a placebo.

“Based on the results, we are very confident that 100 micrograms is the correct dose to include in our phase three studies, as we did not see any improvement with 200 micrograms, but we did see additional adverse effects,” Karlin said.

Professor David Nutt, director of the Neuropsychopharmacology Unit in the division of brain sciences at Imperial College London, which researches psychedelics, said in an email that the study results “are very interesting data in what may be a population that is difficult to treat (anxiety)”.

“They expand the potential usefulness of psychedelic treatment beyond depression,” said Nutt, who was not involved in the research. “And again, as with the depression trials, a single dose produces long-lasting effects, probably because it breaks persistent negative thought processes.”

While it was not the primary goal of the study, the results showed that MM120 also improved signs of depression, Karlin said. “We saw rapid and robust improvement in people’s depression symptoms—depression and anxiety have overlapping disease definitions.”

Without use of psychotherapy.

Most research with MDMA and psilocybin has relied on the use of trained therapists who meet and establish a relationship with participants before administering the drug. Those therapists are then available during the “journey” to help each person assimilate the experience, thus helping to ensure the lasting impact of any psychological insights.

The MM120 study, however, was conducted without the use of in-session psychotherapy. Instead, the monitors sat in the room to ensure safety, but spent their time “mostly reading books,” Karlin said.

“While previous research has documented the benefits of combining LSD with psychotherapy to relieve anxiety associated with life-threatening conditions, this groundbreaking study is the first to demonstrate that a single dose of LSD… can effectively treat generalized anxiety without the supplement. of psychotherapy”. said psychiatrist Dr. Gabriella Gobbi, professor and scientist at McGill University Health Center in Montreal and Canada Research Chair in Mental Health Therapeutics. She did not participate in the clinical trial.

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

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

Most of the adverse effects in the study were rated as mild to moderate by participants and occurred primarily on the day of the study, Karlin said. These included feelings of euphoria, illusions and hallucinations, anxiety, abnormal thoughts, headaches, dizziness, nausea, excessive sweating, vomiting, numbness or tingling of the skin, and dilation of the pupils.

A long history of LSD research

When the MM120 clinical trial began in August 2022, it marked the first time LSD had been studied in a medical setting in more than 40 years, Karlin said.

During the 1940s and early 1950s, tens of thousands of patients took LSD and other psychotropics to study its effects on cancer anxiety, alcoholism, opioid use disorder, depression, and post-traumatic stress. stress disorder or post-traumatic stress disorder. “Researchers began to see psychedelics as possible”New tools to shorten psychotherapy..”

But when Harvard University psychologists Timothy Leary and Richard Alpert were fired from the Harvard Psilocybin Project In 1963, after the university discovered that they had been giving LSD to their students, the use of psychedelics for research began to lose its luster.

Leary began speaking publicly, encouraging young people to take LSD recreationally. He quickly became the face of the counterculture drug movement with his signature message“Turn on, tune in, get out.”

LSD was no longer administered solely in the relative safety of a laboratory or a psychiatrist’s office, but began to appear in horror stories about bad “acid” trips at universities and concerts: headlines that appeared alongside images of protests. against Vietnam and Woodstock attendees.

In 1968, the United States banned LSD and research projects were shut down or forced underground. Then came the Controlled Substances Act of 1970, signed by President Richard Nixon. He classified all hallucinogens, including psilocybin, as List I drugs — substances with no “currently accepted medical use” and with a high probability of abuse.

Clarification: This story has been updated to more accurately reflect the FDA approval process.

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