What Exactly is a Psychedelic Medicine?

Science-backed research continues to show the effectiveness of psychedelic compounds in treating various mental health conditions.

The success of these trials opens doors to new compounds becoming potential medicines for treatment and therapeutic application for conditions like depression, anxiety, post-traumatic stress disorder (PTSD), substance use disorder (SUD), and other conditions.

As the prevalence and research surrounding psychedelic medicine continues to grow, a common question that is asked is: What differentiates a psychedelic medicine from a psychedelic drug or compound?

What is a Psychedelic Medicine?

Psychedelic medicines are compounds that have psychoactive properties that affect one’s conscious experience, and are shown by clinical research and trials to be effective in treating a physical or mental health condition.

While there are many compounds or substances that could fall under this classification, in the United States there are currently three compounds that are being reviewed by the US Food and Drug Administration (FDA) as psychedelic medicines with therapeutic benefits: ketamine, psilocybin, and MDMA (3,4-methylenedioxymethamphetamine).

The following compounds, while not officially recognized or approved for their medicinal use by regulatory bodies, have been included in limited clinical trials in the United States or abroad, or are anecdotally considered to have medicinal benefits:

• LSD (lysergic acid diethylamide)
• Ayahuasca
• DMT (N,N-Dimethyltryptamine)
• 5-MEO-DMT (5-Methoxy-Dimethyltryptamine)
• Mescaline (peyote)
• Ibogaine (iboga)

How the FDA Approves Medicines

The FDA approves new medicines —or existing medicines for a new treatment application— in a multi-phase approach. This process relies heavily on clinical trials to ensure the medicine’s safety and efficacy, and does so through increasingly large sample sizes across its three main trial phases before approval:

‍Phase 1 FDA trials test for safety and dosage of the administered medicine in up to 100 healthy volunteers, or those with the condition.

‍Phase 2 FDA trials monitor for efficacy and side-effects of the medicine in several hundred people with the condition.

‍Phase 3 FDA trials continue to monitor efficacy and adverse reactions in up to 3000 volunteers who have the condition.

This determines the viability of a specific medicinal intervention for the condition being treated, while considering:

• Dosage
• Method of administration
• Adverse side effects
• Positive clinical outcomes

As an example, in 2019, the FDA approved esketamine (a ketamine derivative) administered intranasally (as a low-dose nasal spray) after it was proven to be effective in treating treatment-resistant depression.

To learn more about the approval process, the FDA provides an in-depth guide to its drug review process.

Current Psychedelic Medicines

Ketamine

Ketamine is a dissociative psychedelic, and is the only psychedelic medicine available for prescription through licensed clinicians. Due to its original FDA-approved application as an anesthetic in 1970, its decades of clinical application have allowed for a longer period of research and study into its medicinal and mental health benefits beyond anesthetic use. 

Research has shown ketamine can be beneficial in treating a variety of mental health conditions, including depression, anxiety, PTSD, and suicidal ideation. There are other potential areas of application being explored, such as eating disorders, treatment-resistant conditions, and smoking cessation. Ketamine is allowed as an off-label prescription to treat mental health conditions, subject to a clinician’s approval.

As mentioned above, ketamine can be applied in different ways: intravenous infusion, intramuscular injection, intranasal spray, or via tablets or troches. 

Ketamine’s FDA status

In 2019, the FDA approved intranasally-delivered ketamine derivative esketamine as an intervention for treatment-resistant depression (TRD).

Here are a few examples of ketamine studies currently in FDA trial Phases:

‍Phase 1 trials

• Intranasal administration of ketamine for suicidal ideation

‍Phase 2 trials

• Intravenous administration of ketamine for major depressive disorder (MDD)
• Intravenous administration of ketamine for PTSD

Psilocybin

Psilocybin is a psychedelic compound derived from hallucinogenic mushroom varieties, most commonly the psilocybe cubensis family. It is considered a “classical” psychedelic due to its effect as an agonist on the 5-HT2A (serotonin) receptor. LSD, DMT, and mescaline are other compounds considered classic psychedelics that also affect this receptor network.

Despite being the active compound in psychedelic mushrooms, it is not the mushroom bodies themselves that are used in psychedelic therapy, nor as psychedelic medicines. In clinical trials and treatments, synthetic psilocybin is used, and is either ingested or injected.

There are promising studies showing the efficacy of psilocybin as a psychedelic medicine in the treatment of:

• Anxiety
• Depression
• Eating disorders
• Smoking cessation
• End-of-life anxiety

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Psilocybin’s FDA status

While more research is needed, psilocybin is currently moving through FDA clinical trials for approval as a psychedelic medicine. 

Psilocybin has also been given a Breakthrough Therapy designation from the FDA for the treatment of depression, to help push the treatment and medicine through regulatory approval.

MDMA

MDMA is another psychedelic medicine receiving attention from researchers and regulatory bodies. It works primarily on the serotonin system in the brain, and does not normally induce a classical psychedelic experience. For this reason, MDMA’s status as a psychedelic is largely a semantic discussion.

MDMA is often referred to as an empathogen or entactogen, and it has equal potential when compared to other medicines currently being studied for treatment of mental health conditions.

MDMA’s FDA status

MDMA-assisted psychotherapy in the treatment of PTSD and complex PTSD is currently moving through the final stages of FDA approval.

Spearheaded by the Multidisciplinary Association for Psychedelic Studies (MAPS), MDMA-assisted psychotherapy for PTSD has received Breakthrough Therapy designation, and is currently in its final Stage 3 trials of regulatory FDA approval. If successful, as early indicators show, MDMA treatment may be available for use in clinical settings by 2023. 

Where Can I Receive Treatment Using Psychedelic Medicine?

If you think that you could benefit from treatment with psychedelic medicines, or are interested in the experience for yourself, there are currently two potential avenues available to you: clinical research studies, or ketamine treatment. 

If you’re interested in participating in a study, learn how to find, apply, and enroll in clinical research studies.

As mentioned, the only psychedelic medicine currently available for clinical prescription is ketamine or esketamine (Spravato) treatment. Depending on your country, you can find a ketamine clinic or service provider near you. If you’re in the U.S., and you’d like to experience ketamine treatment from the comfort and safety of your own home, see if you’re a candidate for treatment with Mindbloom.

The other psychedelic medicines such as MDMA, psilocybin, or other compounds are all moving through various stages of research or regulatory approval, and are not available to the public at the time of this writing.

Defaulting to the FDA-approval Pipeline is the Current Leading Indicator

The line that separates a psychedelic compound from a psychedelic medicine is not yet agreed upon, though drawing the line at those that have research backing, clinical support, and regulatory approval (such as by the FDA) is a wise decision. 

Just because a psychedelic compound is not currently viewed as a psychedelic medicine does not exclude it from becoming one in the future. Psychedelic therapy is an emerging field. While some psychedelic medicines are in their initial phases of research, they will likely see an increase in research, applications, and accessibility in the years and decades to come.