CLIENT ALERTS – PSYCHEDELICS AND MENTAL HEALTH THERAPEUTICS SEP 06, 2023 Psychedelic-Assisted Therapy – First Professional Practice Guidelines

Published Set of Guidelines Consists of 12 Individually Outlined Points

In August 2023, the American Psychedelic Practitioners Association (APPA), along with the nonprofit BrainFutures, released the first-of-their-kind, professional practice guidelines for psychedelic-assisted therapy.¹

In an accompanying press release,² Natalie Gukasyan, one of the working group members involved in development of the guidelines, stated that the “guidelines provide the beginnings of a framework for stakeholders to consider when evaluating minimum standards of care”³ for Food and Drug Administration (FDA)-approved psychedelic-assisted therapies. David Esselman, executive director of BrainFutures, noted that “[e]ven though FDA approval for the first psychedelic-assisted therapy is still months away, researchers can use these guidelines today to design cutting-edge studies that will lead to new therapies tomorrow.”⁴ The intended audience for the guidelines also includes mental health providers, legislators, regulators, health insurers, educators and patients.

For the purposes of the guidelines, “psychedelic-assisted therapy” refers to psychedelic medications accompanied by psychotherapy. The guidelines’ broad definition of psychedelic medications covers MDMA in addition to the classical psychedelics, but does not include ketamine since standards of practice for subanesthetic ketamine treatment already exist. The published set of guidelines consists of 12 individually outlined points describing foundational principles of practice, accompanied by a discussion of their rationales and applications. A brief synopsis of the guidelines is provided below.

• Guideline 1
  Practitioners should be in good standing with professional licensure and/or certification bodies.
• Guideline 2
  Practitioners should have specialized training in psychedelic-assisted therapy appropriate to their scope of practice.
• Guideline 3
  Practitioners should remain current in fundamental therapeutic competencies such as developing patient rapport and maintaining the highest levels of ethical integrity.
• Guideline 4
  Practitioners should obtain and document informed consent before starting treatment and discuss consent with patients throughout their care. The guidelines note that informed consent for psychedelic-assisted therapy may be more complicated compared to other drug classes and acknowledge the need to balance a patient’s right to withdraw consent at any time with the need to ensure patient safety.
• Guideline 5
  The informed consent process should specifically address use of touch during psychedelic-assisted therapy. The guidelines discuss seven forms of touch: consolation touch, reassuring touch, grounding or reorienting touch, touch intended to prevent a client from hurting his/her self, touch intending to prevent someone from hurting another, self-defense and task-oriented touch (e.g., measuring blood pressure or wiping a chin). They note that a distinction exists between the first three forms of touch, which the patient has a right to refuse, and the latter four, which may be necessary to safeguard safety. Sexual touch, hostile or violent touch, and punishing touch are prohibited.
• Guideline 6
  Practitioners should thoroughly screen patients in accordance with existing evidence, guidelines and clinical judgment, as psychedelic-assisted therapy may be inappropriate or contraindicated for patients with specific conditions or who take certain medications.
• Guideline 7
  Practitioners should develop rapport with patients during the preparatory sessions, which should include cultural humility and sensitivity.
• Guideline 8
  During the preparatory sessions, practitioners should educate the patient about the medication administration session, including providing detailed logistical information, welcoming patients to share their personal histories, and reviewing the range of possible experiences.
• Guideline 9
  Practitioners should provide safe and therapeutic medication administration experiences in a comfortable and confidential setting and ensure a safe discharge from treatment.
• Guideline 10
  Practitioners should monitor for adverse events, including persisting adverse events, during and after the medication administration sessions.
• Guideline 11
  During the integration sessions, practitioners should aid the patient in processing their experience and in integrating desired changes into their lives.
• Guideline 12
  Practitioners should coordinate with other providers to ensure continuity of care.

In contrast to clinical practice guidelines, which would cover specific treatment recommendations for a medical condition, professional practice guidelines, such as this one, cover areas of practice. The authors of the guidelines note that they did not include information on specific psychedelic medications or doses and urge practitioners to use clinical judgment when applying these guidelines to individual patients. It is also unknown if the FDA or other regulatory bodies will place restrictions on the kinds of professionals permitted to administer psychedelic-assisted therapy or otherwise impose additional limitations on how such therapy is to be conducted.

The authors point out that the guidelines were not based on a systematic review of the literature, but instead were based on “consensus and familiarity with the body of literature.”⁵ They argue that this is typical in the development of professional practice guidelines and note that clinical trials for psychedelic medications focus on assessing safety and efficacy and rarely include data on the precise role of the psychedelic-assisted therapy practitioner. In addition, research in this field has been hindered by the classification of psychedelics as Schedule I controlled substances. The authors further discuss that clinical trials of psychedelic medications are often conducted in racially homogeneous populations, which limits the understanding of the effects and best use of these therapies in a more diverse, real-world population. Similarly, these clinical trials have generally been conducted in restricted populations, where patients with certain comorbid psychiatric or medical conditions have been excluded. The authors note that this limits the inferences that can be made to broader patient populations.

Because research in this area has been limited, the authors emphasize that the guidelines, although static as a publication at this point in time, are meant to change as research in this area grows. The guidelines will expire two years after their publication, and future versions will be updated with new research and regulatory developments that are bound to change the landscape significantly following FDA approval of psychedelic-assisted therapies. The authors also call attention to the need for more data in diverse patient populations, a code of ethics for the field and inclusion of psychedelic-assisted therapy in clinical practice guidelines. They also call for development of additional infrastructure such as independent certification for psychedelic-assisted therapy practitioners and accreditation for education programs in psychedelic-assisted therapy.

As stated by another working group member, Andrew Penn, “The Professional Practice Guidelines are an important next step in the evolution and professionalization of psychedelic therapy. By seeking to clarify and define concepts such as consent, appropriate screening of patients, professionalism and ethics, safety, patient preparation, coordination with other providers, and integration of psychedelic therapy experiences, these guidelines will help to protect patients and advance the safe use of psychedelic medicines in professional settings.”⁶

Our attorneys remain ready to provide advice and guidance on the professional practice guidelines for psychedelic-assisted therapy. For further assistance, please contact any of the attorneys on our Psychedelics and Mental Health Therapeutics Industry Team or the Phillips Lytle attorney with whom you have a relationship.