Australian Approval of Psychedelic Therapy using MDMA and Psilocybin, But Hold Off on Celebration Until More Evidence Emerges.

Starting July 1, 2023, Australian psychiatrists will be able to prescribe patients with MDMA and psilocybin to treat certain mental disorders, as announced by the Australian Therapeutic Goods Administration in early February 2023. Despite being banned in many countries and only available illegally, the use of these drugs has been approved in Australia for the treatment of post-traumatic stress disorder with MDMA and treatment-resistant depression with psilocybin.

Although the medications have not been officially registered in the country, psychiatrists are given permission to use them in their practices. However, it is still against the law to use psychedelics for recreational purposes. In the past, these drugs were only accessible in some countries for the purpose of clinical trials or for specific patients.

The approval of psychedelic therapy in Australia by the regulator is a result of a growing number of scientific studies.

Psychedelic therapy was extensively researched in the mid-20th century but was eventually discontinued and added to the list of prohibited substances. In the past two to three decades, activists and researchers have been advocating for permission to conduct clinical trials of these substances. As a result, research centers specializing in these studies have emerged, mainly in the US.

At present, there are 36 clinical trials underway to study the effects of psilocybin on various illnesses, and around 50 studies have either been completed or are still ongoing. Scientists are investigating the impact of psychedelics on individuals with depression, post-traumatic stress disorder, alcohol dependence, eating disorders, and other illnesses that cannot be treated with conventional methods.

Studies are not only being conducted to determine the efficacy of these substances but also to understand how they work. Psychedelics are believed to have a longer-lasting effect than other psychiatric drugs, such as antidepressants and neuroleptics.

While psychedelic therapy has the potential to be a new form of treatment, there is currently more excitement surrounding it than scientific evidence.

The potential for this therapy to be a new form of treatment is causing excitement, but there is limited scientific data available.

Articles in the media with optimistic headlines about psychedelic therapy frequently surface, however, despite the growing number of studies, the scientific evidence is limited. The largest studies usually only include a few hundred participants, which would not garner much attention if they were studying the efficacy of antidepressants or hypertension drugs. Psychiatrist Alexander Lebedev, who focuses on psychedelic research, has discussed the restrictions of current studies in one of his speeches.

The majority of current research studies are based on small sample sizes, which calls for extra caution when interpreting the results. The risk of observing effects due to random events, known as statistical outliers, is not the only concern. In the initial stages of psychedelic therapy research, only a carefully selected and limited number of patients are admitted into clinical trials, leading to a higher likelihood of obtaining positive results.

The issue with most contemporary studies is that they tend to exclude patients with other mental disorders, heart diseases, and other health issues. This creates a disparity between the study participants and the actual population, as many individuals have multiple illnesses and conditions. As a result, the effects of these drugs may differ outside of clinical trials.

Psychedelic therapy is a unique form of treatment that goes beyond simply ingesting psychedelics. It starts with a specialist speaking to the patient to discuss the upcoming experience, followed by taking the necessary substance in a comfortable setting. Trained specialists are present during the psychedelic experience to assist the patient if any uncomfortable situations arise.

After the experience, the psychotherapist begins to help the patient modify their behavior based on their psychedelic experience. At Johns Hopkins University, guides who have been specially trained communicate with research participants to help them work through their experiences. According to Mary Cosimano, the director of the guide service, it is crucial to work with the acquired psychedelic experience, otherwise the person’s life will not change.

As activist Sasha Astran has noted, psychedelics have the ability to dramatically shift one’s perspective and reorganize their system of values. However, it is up to the individual to implement changes in their behavior to stop suffering and become more effective. The psychedelics simply provide guidance, but the work must be done by the person themselves.

There are several realities of psychedelic therapy that are worth noting

Specialists with proper training are necessary.

The use of psychedelic therapy should only be conducted by individuals with proper training and expertise. In Australia, only psychiatrists with specific authorization are allowed to prescribe MDMA or psilocybin. Established research centers that have been studying psychedelic therapy for an extended period offer specialized courses for individuals who wish to assist others during their psychedelic experience. This puts constraints on the availability and accessibility of this form of therapy.

Adverse reactions

Psychedelics, similar to other medications, can produce negative side effects. Nonetheless, there are no dependable statistics on this issue and the array of adverse reactions that may occur can range from nausea to suicidal thoughts, like with their efficacy.

It’s important to keep in mind that the participants in current research are thoroughly screened. According to psychiatrist Alexander Lebedev in a speech, great care is taken to eliminate individuals with psychiatric disorders and those who have family members with schizophrenia or bipolar affective disorder from these studies. This is done to prevent the use of psychedelics from causing a psychosis and triggering a disorder, which is a hallmark of psychoses. Unfortunately, outside of clinical trials, the selection of patients may not be as strict, resulting in potentially worse outcomes.

Cost

Clinical trial participation is without charge. However, in other instances, accessing this therapy may require patients to pay out-of-pocket. In Australia, insurance does not cover psychedelic therapy, so patients will have to bear the cost themselves, which includes both the drug and the support from specialists.

Currently, there are no active patents on psychedelics, and if and when they become widely available, anyone will be able to manufacture them. It’s probable that multiple companies will quickly register them, which may affect their cost, but it should still remain relatively low. Meanwhile, efforts are underway to synthesize new drugs that will be patented, which is likely to increase their cost.

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