Over the past several years, I have been watching with great anticipation the trajectory of the clinical trials for Psychedelic Assisted Psychotherapy (PAP).
PAP is a therapeutic approach combing the use of psychedelic substances like MDMA, LSD, or Psilocybin with traditional (talk) psychotherapy. This treatment gets administered in a professionally monitored environment and aims to create rapid and long-lasting psychological and behavioral changes for individuals suffering from persistent disorders, such as PTSD.**
MDMA (3,4-methylenedioxy-methamphetamine), commonly known as Ecstasy or Molly, is a synthetic drug that acts as both a stimulant and a mild psychedelic. It is known for producing feelings of pleasure, emotional warmth, increased energy, and altered sensory perception which is why it has often been used in club settings as a part of so-called “rave culture”.
LSD (Lysergic acid diethylamide) is a powerful hallucinogenic drug that alters perception, mood, and various cognitive processes. It is known for causing visual and auditory hallucinations, as well as profound changes in thought and emotion.
Psilocybin is a naturally occurring hallucinogenic compound found in certain types of mushrooms, often referred to as “magic mushrooms”. It is known for causing altered perception, hallucinations, and changes in mood and thought.
During PAP, patients receive a pharmaceutical-grade psychedelic drug in a medically safe way, followed by psychotherapy sessions tailored to their experiences. The process typically involves preparation sessions, treatment sessions with the drug, and integration sessions to help patients process and incorporate the insights gained.
PAP is considered an innovative treatment model because it synergizes the effects of the drug and psychotherapy, leading to significant improvements after a short course of treatment.
So far, this new approach to treatment has been looking very promising, especially for treatment resistant conditions. Example studies:
- A proposed mechanism for the MDMA-mediated extinction of traumatic memories in PTSD patients treated with MDMA-assisted therapy.
- Using a MDMA- and LSD-Group Therapy Model in Clinical Practice in Switzerland and Highlighting the Treatment of Trauma-Related Disorders.
- Psilocybin and MDMA for the treatment of trauma-related psychopathology.
I am most excited by the findings related to MDMA protocols. I have been watching with great interest the work of the Multidisciplinary Association for Psychedelic Studies (MAPS) as their team has worked tirelessly through FDA clinical trials for MDMA treatment protocols. After decades of work to get past stereotypes and draconian restrictions it seemed like the mental health world was on the verge of approval for an MDMA protocol. That is until 4 June 2024 when the advisory committee to the FDA concluded a nine-hour hearing with committee members voting 9-2 that the available data do not show “that the drug is effective” for PTSD, and voting 10-1 that the benefits of MDMA do not outweigh the risks.
What happened? A nice summary of why the committee voted the way they did can be found here:
Adding psychotherapy to drug therapy works, but the FDA may not be able to handle it.
In a nutshell, the FDA advisory committee was unsure how to deal with the psychotherapy/integration piece of the protocol,
“While this application has attracted attention mainly because of the possibility of approving a psychedelic drug as a medical treatment, I believe the key innovation here was the proposal to combine medication and psychotherapy as a bundled intervention. This combination was not convenient for the FDA or its advisory committee, but wasn’t it really a proposal for a best practice that needs to scale across mental health care? I believe this new drug application could serve as a wake-up call for new regulatory processes that would view psychological treatments as key facilitators rather than as co-founders of behavioral change.
Medicines (and mushrooms) are not magic bullets for treating mental illnesses. But combined with evidence-based psychological treatments, they can help people with severe mood and anxiety disorders recover. The combination is the overlooked innovation of this new drug application. People with severe mental illnesses need a regulatory process that addresses this innovation as a feature, not a bug.”
On 11 August 2024 the FDA will meet to make their final decision. I’ll be watching with great interest. If the FDA agrees with the advisory committee and withholds approval of the MDMA protocol it will be a set-back. Full stop! But let’s all hope their is a path forward. Maybe there is a silver lining in recognizing that there is little to no oversight with psychotherapy protocols and practices (in general!), a major issue identified in the advisory committee’s actions, and ultimately why they voted “no”. I share many of those concerns! This is why I typically do not support current Ketamine treatment practices. Where is the oversight? Where is the integration? Results of MAPS clinical trials are powerful and they are clearly showing us that talk therapy is a part of what makes PAP effective, psychotherapy is a feature of the protocol, not a bug.
“Medicines are not magic bullets for treating mental illnesses…combined with evidence-based psychological treatments, they can help people…the combination is the overlooked innovation of this new drug application…it is a feature, not a bug.”
Dr. Thomas R. Insel, STAT, 25 July 2024
The Future of Psychedelic Medicine: A Conversation with Jennifer Mitchell and Sarah Abedi (Making Sense with Sam Harris #377)
**Ketamine often gets lumped into discussions of PAP, but for now based on the differences of effect experienced in human perception, I’m holding Ketamine as a separate treatment. Ketamine differs from other psychedelics in several key ways:
- Mechanism of Action: Ketamine primarily affects the brain’s glutamate system and NMDA receptors, whereas classical psychedelics like LSD, psilocybin (magic mushrooms), and DMT primarily act on serotonin receptors.
- Effects: Ketamine induces dissociative effects, creating a sense of detachment from reality and self. Classical psychedelics, on the other hand, often produce more vivid visual and auditory hallucinations and profound alterations in perception and thought.
- Duration: The effects of ketamine are relatively short-lived, typically lasting about 45 minutes to an hour. In contrast, the effects of classical psychedelics can last much longer, ranging from 4 to 12 hours depending on the substance.
- Therapeutic Use: Both ketamine and classical psychedelics are used in therapeutic settings, but they are suited for different conditions. Ketamine is often used for treatment-resistant depression and acute suicidal ideation due to its rapid onset of action. Classical psychedelics are being studied for their potential in treating conditions like PTSD, anxiety, and depression, often through inducing profound, transformative experiences.
- Experience: The subjective experience of ketamine is often described as more gentle and dream-like, while classical psychedelics can evoke intense and sometimes challenging experiences.
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This post does not constitute therapeutic counseling or advice; the contents of this post are provided as a learning resource. We share the contents hoping that if you are in need of mental health support you will reach out to us directly or to a mental health professional in your area.