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.
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.
1 Am. Psychedelic Pracs. Ass’n (APPA) & BrainFutures, Professional Practice Guidelines for Psychedelic-Assisted Therapy (1st ed. Aug. 2023), https://www.appa-us.org/standards-and-guidelines/professionalpracticeguidelines.
2 Press Release, Am. Psychedelic Pracs. Ass’n (APPA) & BrainFutures, American Psychedelic Practitioners Association and BrainFutures Publish First Professional Practice Guidelines for Psychedelic-Assisted Therapy (Aug. 8, 2023), https://www.appa-us.org/ppg-press-release.
3 Id. at 1.
4 Id. at 2.
5 APPA, supra note 1, at 8.
6 Press Release, supra note 2, at 1.