"The groundwork of all happiness is health." - Leigh Hunt

FDA opens door to clinical use of LSD

March 26, 2024 – If you think that LSD is a dangerous illegal drug with no legitimate medical use, re-evaluate.

LSD continues to be illegal, but recent studies show that this powerful compound is generally not dangerous when taken under controlled conditions and that it has the potential to assist some individuals with serious mental illnesses.

The FDA has recently been referred to as a form of LSD as a groundbreaking therapy for the treatment of generalized anxiety disorder. This decision was based partially on a rigorously designed drug trial through which about half of the patients who took the drug experienced significant relief from their disease.

The FDA's breakthrough therapy designation expedites the event and review of medicine to treat a serious condition where early evidence suggests the drug could also be higher than available therapies. Accelerating this process could well result in FDA approval of LSD for the treatment of generalized anxiety disorder in the subsequent few years. This approval would mechanically legalize the clinical use of LSD.

There are also two other psychedelic drugs, psilocybin (present in certain mushrooms) and MDMA (higher referred to as the club drug “ecstasy”). have also received breakthrough therapy granted by the FDA and are on the option to approval for treatment-resistant depression and post-traumatic stress disorder (PTSD).

In the LSD process In the study, conducted by an organization called MindMed, 194 volunteers ages 18 to 74 took a purified, stable version of the drug at one in every of 4 different doses or received a placebo. The one-time LSD experience resulted in clinically meaningful improvements on the Hamilton Anxiety Rating Scale—a scale commonly utilized in clinical trials to guage the effectiveness of tension medications and coverings—at week 4. By week 12, there have been 48 % of people that received 100 micrograms of LSD experienced a “remission” of their anxiety, and 65% of individuals within the study had a clinical response to the drug. The average reduction in anxiety moved the 100 microgram group from “markedly ill” to “borderline ill” on a distinct rating scale.

How could that be? Scientists still don't understand exactly how this happens, but extensive research on psychedelic drugs suggests that patients who take them experience a form of mental “reset” that is usually accompanied by mystical feelings.

In Michael Pollan's book How to alter your mind, he quotes researchers who imagine that the individuals who profit most from psychedelic drugs are those that suffer from disorders characterised by mental rigidity, similar to alcohol and tobacco addiction, depression and obsessions. Somehow the experience of opening as much as drug-induced perceptual changes and ego loss helps them break out of those mental shackles.

Research is progressing

Collin Reiff, MD, clinical assistant professor of psychiatry at NYU Grossman School of Medicine, welcomed the FDA's groundbreaking designation of LSD.

“It’s very exciting,” he said. “For one thing, it draws people's attention to the effectiveness of these compounds, which increases people's interest in research. Hopefully this will lead to more grants being approved by the NIH and other government organizations. The designation is essentially a catalyst that will facilitate research and help us understand a new compound and could be a new treatment for generalized anxiety disorder.”

MindMed's next step is to conduct a so-called Phase III study to reveal the security and effectiveness of LSD for GAD in a bigger group of patients. That study is predicted to start later this yr, said Daniel Karlin, MD, assistant professor of psychiatry at Tufts University School of Medicine and chief medical officer of MindMed.

Meanwhile, Reiff said, the businesses in search of FDA approval for psilocybin and MDMA have made progress since they received their breakthrough therapy guarantees several years ago. MDMA for PTSD has been tested in two positive Phase III trials and a brand new drug application has been submitted to the FDA. Compass Pathways, the corporate studying psilocybin for depression, can also be conducting two Phase III trials, and results from one in every of them are expected this summer, he said.

“The challenge isn’t necessarily the research,” Reiff said. “The challenge is how to safely make these compounds available at scale if the results continue to be positive.” How do you be certain that providers are well-trained and there may be equitable access to care? Will insurers reimburse this? There are a variety of things to work out.”

Psychedelics in psychotherapy

One of the most important questions, says Reiff, is whether or not and to what extent psychedelic medications may be used as an adjunct to traditional psychotherapy. Since the revival of any such research lately and going back to earlier clinical trials, the usual protocol is to involve trained psychotherapists within the intervention. The three-part approach includes educating and preparing the patient for the psychedelic treatment, the intervention itself, during which the therapist could also be present, and a post-trip “integrative” session through which the patient and therapist discuss what the person has learned has itself from experience.

In contrast, the MindMed study omitted psychotherapists after they referred patients to the study. Karlin noted that other studies haven't rigorously tested the worth of using psychotherapists in psychedelic interventions and said his company aimed to check the “drug-only effect.”

The patients on the trail were informed before their treatment. When they took the LSD, two non-therapeutic observers were within the room with them to supply support and assistance in the event that they encountered difficulties during their journey. Afterwards, says Karlin, “patients returned to the clinical facility for assessments and as part of that process, they had the opportunity to ask questions about their session.”

Karlin said the Phase III trial might be similarly designed, and he stressed that the drug company wants to search out out whether therapists are really needed to realize significant advantages. If LSD is approved by the FDA for the treatment of generalized anxiety disorders, MindMed plans to make the drug available to each psychotherapists and non-therapists “who wish to use it outside of the context of psychotherapy.”

Reiff said more research is required to find out whether psychedelic interventions can produce higher results when psychotherapists are involved within the treatment. Still, he emphasized the importance of proper training for caregivers of patients taking psychedelic medications.

“The more training, the better. When someone has a panic attack or a challenging experience, it can lead to a positive outcome or we can learn a lot from it. But you need someone there who can accompany the patient well.”

Why the environment must be controlled

Reiff and Karlin agree on one point: for psychedelic drugs to learn patients' mental health, they need to be taken in a strictly controlled environment.

In the clinics where these experiments are conducted, patients typically lie on a couch, perhaps wearing dark eye glasses, and hearken to rigorously programmed music on headphones. The idea is to permit them to give attention to exploring their internal geography, slightly than having to take care of the external environment, which might seem frightening or bizarre.

“Most often in these sessions, people describe a process of self-exploration and consider their relationship with their fear,” Karlin said. “So the point of a comfortable stay is to have nothing that distracts from this inner process. We want people to know they are safe because LSD can be unsettling and confusing and we want to have trained monitors on site and we want them to feel comfortable.”

Will the FDA open Pandora's Box?

One reason that much less research has been done on LSD than on psilocybin or MDMA is the bags that LSD carries with it from its temporary but infamous period of widespread use within the Sixties. But before the drug became illegal in 1968, there have been quite a few studies of its possible clinical use within the Nineteen Fifties and early Sixties. Researchers had documented the advantages of LSD and psilocybin in treating alcoholism, anxiety and depression, amongst other things.

American society turned against LSD after Timothy Leary, a Harvard professor who conducted psychedelic experiments and was fired after offering LSD to his students, began proselytizing concerning the supposed advantages of “acid” for young people typically , Pollan recalls in his book. Bad trips, psychotic breaks, flashbacks and suicides by LSD drinkers caused a stir, and the scientific establishment turned against psychedelics. Nevertheless, a small underground conducted psychedelic research, leading to the studies being conducted today.

The checkered history of psychedelics raises the query of what might occur in larger society if the FDA approves LSD to treat certain mental illnesses. Quite a few unregulated clinics already offer psychedelics in clinical trials or an FDA-approved type of ketamine. And there are still individuals who use psychedelic drugs illegally.

Karlin said he isn't nervous about the potential of abuse, partially since the variety of people in search of help for his or her anxiety and depression usually are not the sort who would search out illegal “street drugs.” Furthermore, one cannot turn out to be hooked on LSD, he noted.

“Although there is always the possibility of substance misuse or misuse, this drug does not result in the patterns of use associated with other drugs that produce dependence.”

Reiff sees LSD, psilocybin and MDMA as recent tools for psychiatrists and psychotherapists. “If we can make it available to people for whom other treatments don’t work, that’s a wonderful thing.”

But he warns that things could spiral uncontrolled as before.

“We want to ensure that practitioners are well trained so that there are no negative consequences. And we want to make sure we don't get it wrong. We got it wrong in the 1960s. The drugs reached the mainstream long before they reached the clinics. All it takes is a few bad headlines to ruin the whole thing. So let’s take it slowly and in small steps.”