Extrapharmacological Safety Topics in Psychedelic-Assisted Psychotherapy

Calder, Abigail; Hasler, Gregor

doi:10.1001/jamapsychiatry.2023.1031

Cited by 9 publications

(4 citation statements)

References 9 publications

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“…Though physical touch has historically been avoided in psychoanalytic and dynamic therapy models, it has become common for clinicians who administer psychedelics to use limited forms of reassuring touch, including holding the patient’s hands or lightly touching their shoulders . Physical touch is controversial.…”

Section: Seven Essential Elements Of Informed Consentmentioning

confidence: 99%

Essentials of Informed Consent to Psychedelic Medicine

Marks,

Brendel,

Shachar

et al. 2024

JAMA Psychiatry

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ImportanceInterest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system.ObservationsDespite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings.Conclusions and RelevanceAnalysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.

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Section: Seven Essential Elements Of Informed Consentmentioning

confidence: 99%

Essentials of Informed Consent to Psychedelic Medicine

Marks,

Brendel,

Shachar

et al. 2024

JAMA Psychiatry

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“…Details of the study are described elsewhere (Calder et al, 2024b). The use of LSD and psilocybin was approved by the Swiss Federal Office of Public Health as part of the exceptional medical use program allowing PAT in Switzerland (Calder and Hasler, 2023). Doses ranged from 100-200µg LSD base (>99% purity, Lipomed AG, Arlesheim, Switzerland) or 10-25mg psilocybin dihydrate (99.7% purity, ReseaChem GmbH, Burgdorf, Switzerland).…”

Section: Patient Sample: Open-label Psychedelic-assisted Therapymentioning

confidence: 99%

Validation of the Swiss Psychedelic Side Effects Inventory: Standardized assessment of adverse effects in studies of psychedelics and MDMA

Calder,

Hasler

2024

Preprint

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Introduction: Studies of psychedelic-assisted therapy with LSD, psilocybin, MDMA, and related substances show clinical promise but inadequately assess side effects. Measuring side effects is challenging because they are not always easily differentiated from treatment effects or disease symptoms and show high heterogeneity, variable duration and impact, and sensitivity to context. A systematic questionnaire describing important characteristics of side effects of psychedelics and MDMA would greatly improve on previous methods. We aimed to create a standardized tool for recording clinically relevant side effects of psychedelics and MDMA, including their severity, duration, impact, and treatment-relatedness.Methods: We constructed the Swiss Psychedelic Side Effects Inventory (SPSI) based on insights from previous research. It was pilot tested in 145 participants from three studies. Structured feedback from an expert panel was used to improve validity and feasibility. Results: The final SPSI contains 32 side effects and standardized follow-up questions about their severity, impact, treatment-relatedness, and duration. It is compatible with any study design and can be administered as an interview or self-report at any timepoint after treatment with psychedelics or MDMA.Limitations: The SPSI omits relatively unimportant side effects for brevity’s sake, though space for additional symptoms is given. Future studies are needed to confirm its validity in different contexts.Conclusions: The SPSI is available in English and German for collecting systematic data on side effects from psychedelics and MDMA. This information is vital for improving clinical decisions, informed consent, and patient safety.

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“…These kinds of concerns are being expressed by many others. Especially trenchant are Smith and Appelbaum on legalization (Smith et al, 2021) and Yaden et al on hype (Yaden et al, 2022), while Calder and Hasler offer unique insights derived from the restricted medical use program for psychedelics in Switzerland, operating since 1988 (Calder et al, 2023).…”

Section: Approvalsmentioning

confidence: 99%