How does the FDA panel recommendation apply to psychedelic research?
The field of psychedelic research has been gaining traction, with significant interest in substances like MDMA and psilocybin for their therapeutic potential. Recently, however, the FDA advisory panel recommended against the approval of MDMA-assisted psychotherapy for PTSD, citing that the risks outweigh the benefits. This decision has stirred debate within the psychedelic community about the inherent challenges and varying approaches in psychedelic-assisted therapy.
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What was the FDA panel concerned about?
The FDA advisory committee expressed several concerns about psychedelic-assisted psychotherapy, particularly focusing on MDMA. Among these concerns are the potential for therapist over-enthusiasm and the risk of abuse, as well as blinding issues that may have compromised study results.
Over-Enthusiastic Therapists: The panel noted that some therapists might become overly enthusiastic, potentially biasing the treatment process. Critics within the psychedelic community argue that such enthusiasm can be beneficial, as it remains consistent across both placebo and active treatments. Enthusiastic therapists can foster a more supportive and engaging environment, potentially enhancing the therapeutic experience.
Abuse Potential: Another significant concern is the potential for abuse. Critics argue that any form of psychotherapy—or indeed any human interaction—carries some risk of abuse. To mitigate this, they recommend robust oversight and clear ethical guidelines. Proper training and supervision of therapists can help minimize these risks, ensuring that patients receive safe and effective care.
Functional Unblinding: The majority of the patients in the MDMA Phase 3 trials, correctly guessed their treatment arm (active vs placebo). Functional unblinding is especially pronounced in psychoactive drug research and therefore a concern in most psychedelic research studies.
While these concerns are particularly relevant to MDMA-assisted psychotherapy, it is crucial to recognize that psychedelics are used in various contexts and with different modalities. Each psychedelic substance and its corresponding method of administration can significantly influence the therapeutic process.
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What are the different modalities in psychedelic research?
Psychedelic research encompasses a range of modalities, each with distinct therapeutic approaches and impacts. These modalities can be broadly categorized based on the dosage and the role of the psychedelic in therapy. Here are a few examples of well-known psychedelic treatment modalities:
MDMA-Assisted Psychotherapy (Macrodose):
Effect: MDMA typically involves a macrodose, where the effect is considered to be balanced between internal reflection and external interaction (50/50).
Therapeutic Process: During sessions, patients may alternate between deep introspection with eyes closed and engaging in meaningful conversations with the therapist. This dual approach allows for both emotional processing and verbal expression, making MDMA a versatile tool in therapy.
Psilocybin-Assisted Therapy (Macrodose):
Effect: Psilocybin’s macrodose effect is predominantly internal.
Therapeutic Process: Active talk therapy is usually minimal during the session itself. Instead, significant therapeutic work occurs during the preparation phase before the session and the integration phase afterward. This process helps patients make sense of their psychedelic experiences and apply insights to their lives.
Microdosing:
Effect: Microdosing involves sub-perceptual doses of psychedelics, where the effects are subtle and not typically noticeable.
Therapeutic Process: Psychotherapy in this context is generally limited to preparing the patient. The ongoing administration of microdoses does not require the presence of a therapist or a clinical setting. This modality is more about enhancing daily functioning and well-being rather than inducing profound therapeutic experiences.
MEAI:
Effect: MEAI, developed by Clearmind Medicine, the company I’m heading, is intended to be administered as a pill, not an adjunct to psychotherapy, akin to traditional pharmaceuticals.
Therapeutic Process: The preparation for MEAI is designed to be like any standard traditional medication, involving consultations with a family doctor or psychiatrist. This approach aligns MEAI more closely with traditional pharmaceutical treatments, offering an accessible option for patients.
Ayahuasca Ceremonies (Macrodose):
Effect: Ayahuasca is used in a macrodose during ritualistic ceremonies.
Therapeutic Process: Traditionally, ayahuasca ceremonies do not involve extensive preparation or integration. The relationship between the participant and the healer or shaman is typically focused on the ceremony itself. This practice emphasizes the spiritual and communal aspects of healing.
Effect: MDMA typically involves a macrodose, where the effect is considered to be balanced between internal reflection and external interaction (50/50).
Therapeutic Process: During sessions, patients may alternate between deep introspection with eyes closed and engaging in meaningful conversations with the therapist. This dual approach allows for both emotional processing and verbal expression, making MDMA a versatile tool in therapy.
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Effect: Psilocybin’s macrodose effect is predominantly internal.
Therapeutic Process: Active talk therapy is usually minimal during the session itself. Instead, significant therapeutic work occurs during the preparation phase before the session and the integration phase afterward. This process helps patients make sense of their psychedelic experiences and apply insights to their lives.
Effect: Microdosing involves sub-perceptual doses of psychedelics, where the effects are subtle and not typically noticeable.
Therapeutic Process: Psychotherapy in this context is generally limited to preparing the patient. The ongoing administration of microdoses does not require the presence of a therapist or a clinical setting. This modality is more about enhancing daily functioning and well-being rather than inducing profound therapeutic experiences.
Effect: MEAI, developed by Clearmind Medicine, the company I’m heading, is intended to be administered as a pill, not an adjunct to psychotherapy, akin to traditional pharmaceuticals.
Therapeutic Process: The preparation for MEAI is designed to be like any standard traditional medication, involving consultations with a family doctor or psychiatrist. This approach aligns MEAI more closely with traditional pharmaceutical treatments, offering an accessible option for patients.
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Effect: Ayahuasca is used in a macrodose during ritualistic ceremonies.
Therapeutic Process: Traditionally, ayahuasca ceremonies do not involve extensive preparation or integration. The relationship between the participant and the healer or shaman is typically focused on the ceremony itself. This practice emphasizes the spiritual and communal aspects of healing.
Throwing the baby out with the bathwater?
Psychedelics represent a diverse and evolving field of therapeutic research that holds great promise, in which each modality offers unique benefits and challenges. For example, microdosing modalities are not expected to have issues with functional unblinding, and treatment that does not include psychotherapy will have less abuse potential. As the scientific community continues to explore these substances, it is essential to address concerns about safety and efficacy while appreciating the distinct characteristics of each psychedelic and its therapeutic application. Understanding the varied modalities of psychedelic therapy can help tailor treatments to meet individual needs, ultimately advancing the potential of psychedelics in mental health care.
Source link : https://www.psychologytoday.com/za/blog/psychedelics-to-the-rescue/202406/not-all-psychedelics-are-made-equal?amp
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Publish date : 2024-06-28 00:42:08
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