Psychedelic-Assisted Therapy – First Professional Practice Guidelines

Thursday, September 7, 2023

Source: Phillips Lytle LLP

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.

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