FAQ

Psychedelics are a family of compounds that create altered perception, mood and cognitive processes in users. Well known psychedelics include psilocybin, MDMA and ayahuasca. For thousands of years, psychedelics were used by indigenous cultures before being re-discovered by the West in the 1950s and then championed by the counter culture movement of the 1960s. Data from current FDA clinical trials suggests that certain psychedelics can help treat indications including anxiety, depression, PTSD and addiction.

Psychedelics are broadly classified as Schedule I substances in the U.S., meaning that they are illegal for use outside of regulated clinical trials. Many psychedelics, including MDMA and psilocybin, are under investigation in ongoing FDA clinical trials.

In the Netherlands, psilocybin mushrooms have been illegal since 2008. However, the government only outlawed the mature mushroom stage of psychedelic fungi, meaning that truffles containing psilocybin are still legal to buy and consume. Truffles are the underground fruiting bodies of fungi. Psilocybin truffles are considered legal as they are not listed in the Dutch Opium Act (Opiumwet).

In the US, ketamine is a Schedule III drug, meaning that it has an accepted medical use (anesthesia). Ketamine is commonly prescribed off-label for conditions including treatment-resistant depression.

The Multidisciplinary Association for Psychedelic Studies (MAPS), is leading a clinical trial investigating MDMA-assisted psychotherapy as a treatment for PTSD. The FDA has designated MDMA-assisted psychotherapy for PTSD a Breakthrough Therapy, and has come to an agreement with MAPS on Phase III protocol designs. The FDA could approve MDMA as a treatment for PTSD as early as 2022. The FDA has also approved MAPS’ application for an Expanded Access program, otherwise known as a compassionate use program. This allows 50 US based PTSD patients facing a serious or life-threatening diagnosis early access to MDMA-assisted psychotherapy prior to the completion of Phase III trials.

The Usona Institute and Compass Pathways are separately conducting late-stage Phase II clinical trials investigating psilocybin as a treatment for two types of depression, major depressive disorder and treatment-resistant depression. Both organizations have been granted Breakthrough Therapy designations by the FDA to expedite their research. It is anticipated that psilocybin will receive FDA approval no earlier than 2024.

Clinical trials are showing promising results using psychedelic-assisted psychotherapy (PAP) to treat a variety of treatment-resistant conditions. In clinical trials, PAP is generally given as 2-3 approximately 8 hour long sessions, each spaced about 30 days apart. Studies indicate that integration, pre and post psychedelic experience, can enhance treatment efficacy. Talk therapy remains an essential component of psychedelic medicine. Patients are given time before, during and after treatment to discuss their experiences.

While medicated, patients are continuously monitored and supported by trained mental health professionals. Psychedelics, in dissociative doses, are not intended to be self-administered in medical uses. In the correct context, psychedelics can be a catalyst enabling healing.

Clinical Psychologist Dr. Rosalind Watts is an expert in psychedelic research and developed the ACE Model, (Accept, Connect, Embody) as a way to help people make sense of their deep psychedelic journey, and take the learning to integrate findings into their daily life.

Research indicates that psychedelics reduce activity in the brain’s default mode network (DMN). The DMN is a group of structures in the brain that connect the cortex to the areas involved in memory, emotion, and other inwardly-focused thinking, like self-reflection. Many conditions including depression and eating disorders are thought to involve repetitive loops of thought and destructive narratives. Psychedelics quiet the DMN giving users a chance to escape these destructive patterns of thought. Acute and long-term use of psychedelics is associated with personality changes impacting peoples’ value systems, cognitive flexibility, and individual and social behaviour. Learn more here.

What happens in the brain when someone takes a psychedelic? Neuroscientist Dr. Robin Carhart-Harris explains.

Ketamine is classified as a dissociative psychedelic and has been safely used as an FDA-approved anesthetic since 1970. Ketamine is now finding uses in psychiatry, as a remedy for treatment-resistant depression. Dosage matters, as well as delivery; ketamine can be injected intravenously (IV), intramuscularly (IM), taken orally (troches), or taken intranasally (Spravato™). Studies show improved symptoms within 2 hours and antidepressant effects for up to a week. Patients should not consider the information contained therein as medical advice and should consult with their physician before using ketamine. For more information, please refer to the FDA’s guidance on ketamine.

Ketamine has been found to be useful for patients who have not experienced full relief of depression from traditional antidepressant medication. Prior to being scheduled for ketamine-assisted psychotherapy, a provider will conduct a full psychiatric evaluation and request lab work to determine if a patient qualifies for ketamine treatment.

A ketamine-assisted psychotherapy (KAP) session is a two-hour experience. During the session, clients lie down in a comfortable chair, wearing eyes shades and listen to calm music. Patients then take a prescribed dose of ketamine that goes under the tongue which takes approximately ten minutes to take effect. At the end of those ten minutes, most people will experience a body-tingling sensation and overall relaxation.

There is a significant amount of dissociation during the experience. Patients often have out-of-body experiences, and experience difficulty moving akin to being in a trance state. Patients stay in a lying position for about an hour. Following this, talk therapy is used to integrate the experience.

During treatment, patients experience an altered mental state, feeling disconnected or in a dreamlike state. Some may experience a slight elevation in blood pressure, confusion, blurred vision, slurred speech, nausea, and vomiting. Most of these side effects usually subside shortly after the infusion.

There are a few theories as to how ketamine improves depressive symptoms, through its influence on glutamate signaling. Ketamine is an N-methyl-d-aspartate (NMDA) receptor antagonist that when used in subanesthetic doses, may increase the expression of glutamate, a powerful neurotransmitter. Glutamate has a particularly important role in a brain process called “long-term potentiation.” Long-term potentiation refers to our brain’s ability to strengthen the connection between certain neurons, leading them to send signals to each other more easily. This is part of how our brains make connections between pieces of information, and is thought to be the basis of memory formation.

In recent years, studies have found that when we are depressed, our brains are impaired with regards to making and strengthening connections, and that improvement in depression occurs in concert with an increase in the ability to make new brain connections. Ketamine treatment has been shown to improve long-term potentiation in just such a manner, though the mechanism of this effect is not fully elucidated.