Washington – The LSD reduced anxiety symptoms in an intermediate phase study published on Thursday, racing the path for additional tests and the possible medical approval of a psychedelic drug that has been prohibited in the United States for more than half a century.
The results of the Mindmed drug manufacturer tested several doses of LSD in patients with generalized moderate to severe anxiety disorder, and the benefits lasted up to three months. The company plans to carry out monitoring studies to confirm the results and then request the approval of the Food and Medicines Administration (FDA).
As of the 1950s, the researchers published a series of articles that explored the therapeutic uses of the LSD, although most of them do not meet modern standards.
“I see this article as a clear step in the direction of reliving that old research, applying our modern standards and determining what the real costs and benefits of these compounds are”Said Frederick Barrett, who runs the psychedelic center of Johns Hopkins University and did not participate in the investigation.
The psychedelic research is rebuking. Psychodelic are in the midst of a popular and scientific resurgence, with conferences, documentaries, books and medical magazines that explore their potential for conditions such as depression, anxiety and post -traumatic stress disorder.
The FDA has designated the psilocybin, the MDMA and now the LSD as possible “innovative” therapies based on the first results.
Even so, drugs have not had an easy path to the market. Last year, the FDA rejected the MDMA, also known as ecstasy, as a treatment for posttraumatic stress disorder, citing defective study methods, possible research bias and other problems.
The new study of the LSD, published by the Journal of the American Medical Association, addresses some of those problems.
The MDMA, like many other psychedelics, was tested in combination with hours of conversation therapy by trained health professionals. This approach was problematic for the FDA reviewers, who said it was difficult to separate the benefits of the drug from those of therapy.
The LSD study adopted a simpler approach: patients received a single dose of LSD, under professional supervision, but without therapy, and then followed up for approximately three months.
The document does not detail how patients were prepared for experience or what type of monitoring they received, which is crucial to understand the research, said Barrett.
“In many cases, people can have subjective experiences so powerful that they may need to talk to a therapist to help them make sense,” he said.
Relieved anxiety, but questions remain. For the study, the researchers measured the symptoms of anxiety in almost 200 patients who randomly received one of four doses of LSD or a placebo. The main objective was to find the optimal dose of the drug, which can cause intense visual hallucinations and, occasionally, panic or paranoia feelings.
At four weeks, patients who received the two highest doses had significantly lower anxiety scores than those who received placebo or lower doses. After 12 weeks, 65% of the patients who took the most effective LSD dose (100 milligrams) continued to show benefits and almost 50% were considered to be referred to. The most common side effects included hallucinations, nausea and headaches.
Patients who received simulated pills also improved, a common phenomenon in psychedelic and psychiatric studies, but their changes were less than half the size of those who received the real drug.
The research was not immune to the problems observed in similar studies.
Most patients could correctly guess if they had received LSD or a simulated pill, which undermines the “blinded” approach that is considered fundamental to establish objectively the benefits of a new medicine. In addition, an important part of patients both in the placebo group and in treatment abandoned the study at the beginning, which reduced the final data set.
Nor was it clear how long the patients could continue to benefit.
Mindmed is carrying out two large tests in the late phase that will track patients for a longer period of time and, if they succeed, will be presented for approval to the FDA.
“It is possible that some people need a new treatment,” said Dr. Maurizio Fava of the Mass General Brigham Hospital, the main author of the Mindmed study and advisor. “How many portrays, we still don’t know, but the lasting effect is quite significant.”
Interest of Donald Trump’s administration. The Secretary of Health Robert F. Kennedy Jr. and other administration officials have expressed interest in psychedelic therapy, suggesting that he could receive an accelerated review for veterans and other people suffering from psychological injuries.
Generalized anxiety disorder is one of the most common mental disorders, which affects almost 3% of adults in the United States, according to national health institutes. Current treatments include psychotherapy, antidepressants and drugs against anxiety such as benzodiazepines.
The possibility of using LSD as a medical treatment is not new.
In the 1950s and 1960s, more than 1,000 articles were published that documented the use of LSD to treat alcohol addiction, depression and other conditions. But a federal reaction was in full swing at the end of the 1960s, when psychedelics were linked to counterculture figures such as Timothy Leary, the former Harvard professor who famously promoted drugs as a means to “turn on, tune in and abandon.”
A 1970 law that classified the LSD and other psychedelics such as drugs from list 1, without any medical use and with high abuse potential, essentially stopped research in the United States.
When a handful of nonprofit organizations began to reassess drugs in the 1980s and 1990s, they focused on hallucinogens less known as MDMA and Psilocybin, the main ingredient of magical fungi, to avoid the historical controversies surrounding the LSD.
“The LSD was right in front of everyone, but Mindmed is the first company that really decided to evaluate it.”Said Fava.