How does the FDA panel recommendation apply to psychedelic research? – Psychology Today

At any moment, someone’s aggravating behavior or our own bad luck can set us off on an emotional spiral that could derail our entire day. Here’s how we can face triggers with less reactivity and get on with our lives.
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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.
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.
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.
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:
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.
Adi Zuloff-Shani, Ph.D., is a biomedical research and development executive and the CEO of Clearmind Medicine.
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At any moment, someone’s aggravating behavior or our own bad luck can set us off on an emotional spiral that could derail our entire day. Here’s how we can face triggers with less reactivity and get on with our lives.

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