The Shifting Landscape of Psychedelics in Mental Health: Promising Therapy or Complex Terrain?

The realm of mental health is undergoing a transformative shift as psychedelics gain prominence as potential treatments for various psychological disorders. However, the profound alterations these substances induce in consciousness raise ethical and clinical considerations. Experts emphasize the need for robust regulatory frameworks, specialized training, and standardized therapeutic protocols to ensure the safety and effectiveness of these treatments.

Psychedelics occupy a pivotal junction in the context of mental health, offering novel avenues for addressing challenging conditions like treatment-resistant depression and post-traumatic stress disorder (PTSD). Yet, their capacity to reshape mental states also presents distinct ethical and clinical challenges.

A recent article published in Nature Medicine sheds light on the criticality of safeguarding patients during altered states of consciousness. Leading psychiatrists, psychologists, and psychotherapists underscore the urgency of establishing regulatory structures and collaborative efforts to unlock the potential benefits of this emerging treatment paradigm.

The exploration of alternative therapies for refractory mental health disorders has brought psychedelics like psilocybin, found in ‘magic mushrooms,’ and LSD, substances previously associated with counterculture, into the spotlight of clinical practice. Alongside these ‘unconventional’ psychedelics are substances like ketamine and MDMA, increasingly recognized for their therapeutic potential.

For instance, synthetic psilocybin has shown promise in mitigating depression and anxiety linked to cancer diagnoses. Its efficacy is also under investigation for conditions such as obsessive-compulsive disorder, eating disorders, and substance use disorders.

Although typical and atypical psychedelics differ in their subjective effects, both are generally considered safe with limited abuse potential. Nonetheless, a smooth transition from clinical trials to standard clinical practice is not assured.

According to Albino Oliveira-Maia, senior author of the article and head of the Neuropsychiatry Unit at the Champalimaud Foundation, “Psychedelic therapies have mainly existed within research and clinical studies. However, this landscape is changing. We are witnessing the off-label use of substances like ketamine, previously seen solely as an anesthetic, for treating depression and substance use disorders. This is occurring without clear guidelines, formal regulatory approval, or recommendations for psychological support.”

Distinct from most drug interventions, psychedelic therapies typically incorporate psychotherapy to ensure patient safety and potentially enhance therapeutic effectiveness by shaping drug-induced subjective experiences. The authors emphasize the importance of assessing the therapeutic value of accompanying psychotherapy.

Oliveira-Maia explains, “If psychotherapy during the psychedelic experience provides substantial additional benefits, defining and standardizing optimal therapeutic procedures becomes essential. We also need to ensure that the potential of psychedelics doesn’t compromise patient safety.” Psychedelics can heighten suggestibility and intimacy, increasing vulnerability to potential abuse and boundary violations within the therapist-patient relationship.

A notable instance of such transgressions occurred during a Canadian clinical trial involving MDMA-assisted therapy for PTSD. An unlicensed therapist and a participant reached an out-of-court settlement for a sexual assault claim. These incidents underscore the need for certified, professionally trained practitioners, regulatory oversight, and enhanced informed consent procedures to address potential misuse and patient susceptibility during altered states of consciousness.

Ana Matos Pires, co-author and Director of the Mental Health Department at Unidade Local de Saúde do Baixo Alentejo, emphasizes the collective effort required. “This demands involvement not only from prescribing physicians and administering psychologists but also from various stakeholders at national and international levels. Regulatory bodies, such as the US Food and Drug Administration and European Medicines Agency, policymakers, ethics boards, pharmacists, nurses, and of course, the patients themselves.”

In Portugal, researchers collaborating on psychedelics are engaging with professional psychiatric and psychological societies, as well as ethical authorities, to proactively address potential regulatory challenges associated with mainstream adoption of these treatments. Matos Pires asserts, “Our proactive approach can serve as a model for other nations preparing to incorporate psychedelic treatments into clinical practice. Health literacy is crucial; the public must be informed about these treatments. Psychedelic therapies are not a panacea but an additional tool for treating mental illness.”

Numerous aspects require clarification, from optimal dosages and strategies to counter adverse effects to determining ideal treatment settings, whether traditional hospital environments or alternative therapeutic spaces. Time is of the essence. Australia recently announced its intent to permit therapeutic use of MDMA and psilocybin from July 2023, while the FDA might approve MDMA for PTSD treatment as early as 2024.

Luís Madeira, co-author and President-elect of the Portuguese Society of Psychiatry and Mental Health, highlights the potential benefits of psychedelics but urges caution. He emphasizes the need to recognize challenges and avoid hastening the process. As trials typically pair psychedelics with therapy, further research is essential to understand the individual effects of both the drug and the therapy. One might prove more efficacious than the other.

Madeira notes the difficulty of conducting unbiased double-blind studies due to the distinctive psychoactive effects of psychedelics. Additionally, the question of accessibility within the public health system arises, given that each psychedelic experience can span eight hours and requires two trained therapists. “Group therapy might offer a solution, enabling therapists to treat multiple patients simultaneously and reducing costs, thereby making the treatment more viable within public health systems.”

The article’s first author, Carolina Seybert, Clinical Psychologist at the Champalimaud Clinical Centre, underscores the need for flexibility. “These protocols must be adaptable as our understanding of these therapies evolves. In a rapidly evolving field, where our knowledge base constantly updates, our guidelines and regulations must be not only robust but also flexible. We need a uniform framework that can be adjusted as new information emerges. Leaving this to individual self-regulation could lead to substantial variation in patient experiences.”

In a way, our exploration of psychedelics in mental health mirrors the essence of the treatment itself – a journey into uncharted territory and novel possibilities. The authors’ article provides timely guidance and a clear understanding of the ethical and regulatory challenges ahead.

Reference: “Psychedelic treatments for mental health conditions pose challenges for informed consent” by Carolina Seybert, Gonçalo Cotovio, Luís Madeira, Miguel Ricou, Ana Matos Pires, and Albino J. Oliveira-Maia, 14 June 2023, Nature Medicine.
DOI: 10.1038/s41591-023-02378-5

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More about Psychedelic Therapy

• Nature Medicine article: Psychedelic treatments for mental health conditions pose challenges for informed consent
• US Food and Drug Administration: FDA
• European Medicines Agency: EMA
• Portuguese Medical Association: PMA
• Champalimaud Foundation: Champalimaud Foundation
• Unidade Local de Saúde do Baixo Alentejo: ULSBA
• Portuguese Society of Psychiatry and Mental Health: SPMP