US drugs regulator gives LSD ‘breakthrough’ status for treating anxiety – why that is so significant

LSD was by accident discovered by Albert Hofmann on the Sandoz pharmaceutical company in Switzerland in 1938. It was apparently uselessbut from 1947 it was marketed as “a cure for every part from schizophrenia to criminal behavior, ‘sexual perversions’, and alcoholism”. It failed to search out its area of interest.

Now, over 80 years later, it could finally have found one – apart from expanding consciousnessthat’s. A brand new study shows that it is extremely effective at treating generalised anxiety disorder for as much as 12 weeks with only a single dose. And it’s fast acting.

General anxiety disorder (hereafter referred to easily as “anxiety”) is a mental health condition characterised by excessive worry, fear and anxiety about on a regular basis situations. It affects about 6% of adults during their life. Treatments include psychotherapy, akin to cognitive behavioural therapy, in addition to medications, akin to antidepressants and benzodiazepines.

Psychotherapy is pricey and takes weeks or months, while drugs have to be taken day by day for weeks, months and even years. And these can have side-effects. Benzodiazepines are very addictivewhile SSRIs (the most recent generation of antidepressants) have a number of side-effects including sexual dysfunction.

In addition, there are numerous anxious patients for whom not one of the established drugs work. Clearly, latest drugs for anxiety are needed.

A clinical trial within the US by the biopharmaceutical company MindMed has shown that a type of LSD (lysergide d-tartrate), given at a comparatively low dose, can effectively treat individuals with anxiety.

Patients got the drug at 25µg, 50µg, 100µg or 200µg. This was a phase 2b clinical trial, which is where different doses of a drug are tested in a bunch of individuals with the illness in query. The purpose is to search out a dose that works while having acceptable side-effects. It was found that the 100µg dose was very effective while having only relatively minor side-effects.

The study used the Hamilton anxiety scale to measure anxiety levels. Researchers found improvements in anxiety levels inside only two days of administration of their drug.

Further improvements were seen 4 and 12 weeks into the study. At 12 weeks, 65% of the patients were less anxious, with 48% of patients not meeting the clinical criteria for anxiety.

The results were so remarkable that the Food and Drug Administration (the organisation that approves latest drugs within the US) has designated this a “breakthrough” drug. This means the FDA will work closely with MindMed through the next phase of testing in humans (called “phase 3”). This is where a bigger group, normally as much as 3,000 patients, is tested.

In phase 3, LSD may be tested against established drugs for anxiety to find out if it really works as well or possibly even higher than those already in clinical use.

Psychedelics shown to treat a spread of disorders

Previous studies have examined certain illicit drugs, normally hallucinogens or psychedelics, as treatments for depression, post-traumatic stress disorder, anxiety and addiction. LSD, ecstasy (MDMA), ketamine, ayahuasca and psilocybin all seem useful in various mental health conditions.

A single dose of ketamine can alleviate depressive symptoms for as much as per week. The current study by MindMed is the primary positive single-dose study, with no psychotherapy, of LSD for anxiety.

It is incredible to think that the US war on drugs which began with Richard Nixon in 1970, and the resultant difficulties in scientifically examining these illicit drugs, has lasted this long.

Most of those drugs were outlawed and scheduled as having “no accepted medical use”. Five a long time later, we’re finally finding clinical uses for these drugs.

The data from the MindMed study has been sent to a top science journal for peer review, so we must always not get carried away just yet. A phase 3 trial continues to be needed. However, if a single dose of LSD does work for 12 weeks, then this is really remarkable. We might be on the verge of a brand new era of treatments for mental health problems.