The FDA has approved the use of MDMA by therapists -- to better prepare them to administer MDMA-assisted psychotherapy. FDA Endorses Psychedelics ‘Guided Experience’ Model

The Food and Drug Administration is authorizing the legal use of MDMA by therapists, to better prepare them to administer MDMA-assisted therapy for PTSD

Psychedelic drug-based medicine is “revolutionary” in several respects.

It’s revolutionary in terms of the efficacy being reported in clinical studies – with respect to several different psychedelic drugs and mental health disorders. It appears to be a quantum leap forward in mental health care.

Psychedelic medicine is also revolutionary with respect to the mode of treatment: a “guided experience”.

As most people already know, psychedelic drugs got their name because of their psychoactive (and often hallucinogenic) properties. A therapeutic dosage for most of these substances induces such a psychedelic “experience”.

In more colloquial terms, patients experience a “trip” on psychedelic drugs, and that trip is seen by many/most psychedelics therapists as an integral part of the therapy itself.

Guided experience. Using an altered state of consciousness to overcome rigidly ingrained thought patterns that often prevent true healing of the mental health disorder. Alternately, these psychedelic drugs (and the guided experience that comes with it) simply rewire our brain.

As an example of this, a ‘side effect’ of psychedelics use that has been reported by significant numbers of individuals – with respect to several different psychedelic substances – is reduced color-blindness.

Rewiring the brain to improve function with respect to a ‘permanent’ defect.

It is these properties that has inspired Psychedelic Stock Watch to dub these substances the new Miracle Drugs of the 21st century. Revolutionary therapy. Revolutionary results.

But is it too revolutionary?

A new therapy model, new thinking required

Even advocates of psychedelic medicine acknowledge that such guided experiences will not be an appropriate therapy for all patients. Indeed, some genetic markers, behavioral profiles, or past/current drug use preclude psychedelics-assisted therapy.

However, with patients properly screened, adverse experiences seem to be relatively minimal. Clinical results (as noted) have been outstanding. In other words, the enormous gains from psychedelic medicine seem to be sustainable in relation to the modest and controlled level of risk.

But would regulatory authorities accept such a relatively radical approach to mental health therapy?

Health Canada was the first regulatory body that provided a concrete basis for optimism.

First, Health Canada granted several special legal “exemptions” to allow terminally-ill patients to receive psilocybin-assisted therapy to ease their end-of-life distress, specifically feelings of depression and/or anxiety.

Then Health Canada went significantly further. It provided additional legal exemptions to therapists.

The reasoning? If you’re going to endorse a “guided experience” model of mental health therapy, it stands to reason that the therapy will be more consistent and effective if administered by a “guide” with personal experience in the use of that psychedelic substance.

Radical thinking for a public regulatory body.

Now it’s the FDA’s turn.

FDA approves the legal use of MDMA by psychedelic drug therapists

In the United States, MDMA appears to be the substance clearly in the lead in terms of obtaining regulatory approval (and the necessary drug rescheduling).

MDMA-assisted therapy is seen as the best therapeutic option for treating post-traumatic stress disorder (PTSD). A formal clinical trial – by MAPS – is already into a Phase III clinical trial and reporting outstanding results.

PTSD is one of the stress-related mental health disorders that represent the Mental Health Crisis. It is at epidemic proportions in the United States among its armed forces personnel.

Compounding this crisis for the U.S. military, the Department of Veterans Affairs has been having very limited success in providing PTSD treatment to veterans. Indeed, the Department of Defense is the world’s largest individual donor to psychedelic drug research.

The Food and Drug Administration has already granted MAPS Breakthrough Therapy Designation for its research, fast-tracking the clinical trials process.

Now it has gone even further.

On May 12, 2021, the FDA granted approval to the Multidisciplinary Association of Psychedelic Studies (MAPS) to “study MDMA” through the use of MDMA by healthy volunteer therapists. Again, as with the Health Canada exemption for therapists, this is an implicit endorsement by the FDA of the “guided experience” model of psychedelics-assisted therapy: allowing the guides to become experienced themselves.

Given the often-traumatized state of PTSD sufferers, this seems like a particularly wise decision by the FDA. To maximize the rate of success on what already appears to be a very successful therapy, make sure the therapists themselves receive the best training/preparation to conduct such therapy sessions.

A major step forward in psychedelic drug development

This is not just a significant step forward for MAPS. It sets a precedent. Other psychedelics clinical trials are already underway in the United States under the regulatory supervision of the FDA.

Other practitioners and institutions involved in psychedelics-based therapies can now also apply (appeal) for permission for such approved usage of these substances.

It’s not an irreversible step along the road toward the formal approval of such therapies and the normalization of drug laws. But it’s a very significant one.

Would the FDA’s relatively conservative approach to drug regulation preclude it from embracing the relatively radical treatment model of psychedelics-assisted therapy?

As of today, the answer to this question appears to be “no”.

One good reason why investors may want to consider adding a position in psychedelic stocks while these stocks remain in their current trough.
 

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