This trial (n=31) used semi-structured interviews to assess participants’ expectations, experiences, and thoughts on the safety and efficacy of a trial with LSD. Most participants felt safe throughout the study, attributing their feelings of safety to the study structure and support of their attendants, which allowed them to “let go” and immerse themselves in the experience without pre-occupation. Participants endorsed support for the clinical utility of LSD in controlled environments, expressing the belief that LSD is safe and has the potential to help others.

Abstract

“Background: Classic psychedelics show promise in the treatment of mental health conditions; however, more scalable intervention protocols are needed to maximize access to these novel therapeutics. In this proof-of-concept study, perceptions of safety, subjective effects, and beliefs about the clinical utility of lysergic acid diethylamide (LSD) were evaluated among healthy participants (N = 31) administered 50 to 100 µg LSD in a treatment paradigm conceptualized as more scalable than traditional approaches to administering classic psychedelics.

Methods: Semi-structured interviews assessed participants’ expectations, experience, and thoughts on the safety and efficacy of the study design. These interviews were transcribed for thematic analysis relating to perceptions of safety, subjective effects, and beliefs about the clinical utility of LSD.

Results: Most participants felt safe throughout the study, with a minority reporting concerns related to having a challenging experience that diminished over time. Participants attributed their feelings of safety to the study structure and support of their attendants, which allowed them to “let go” and immerse themselves in the experience without pre-occupation. Furthermore, participants reported transcendent, mystical-type experiences characteristic of classic psychedelics, with almost half highlighting the prominent role played by music during the acute period of drug action. Finally, participants endorsed support for the clinical utility of LSD in controlled environments, expressing the belief that LSD is safe and has the potential to help others.

Conclusion: Findings provide preliminary support for the feasibility of this scalable interventional paradigm and set the stage for future critical research with clinical populations.

Authors: Peter S. Hendricks, Heith Copes, Neiloufar Family, Luke T. J. Williams, David Luke & Shlomi Raz

Summary of Perceptions of safety, subjective effects, and beliefs about the clinical utility of lysergic acid diethylamide in healthy participants within a novel intervention paradigm: Qualitative results from a proof-of-concept study

Introduction

The discovery of the 5HT2aR agonist lysergic acid diethylamide (LSD) in 1943 sparked notable scientific interest, but legal proscriptions were enacted and funding was withdrawn, leading to a protracted moratorium on human research with classic psychedelics. However, in 2014, results of the first modern clinical trial of LSD were published.

LSD can occasion transcendent, mystical-type experiences, but can also engender challenging experiences, colloquially known as “bad trips.” To minimize the likelihood and impact of challenging experiences, researchers recommend intensive preparation prior to drug administration, oversight of two attendants or “guides,” and multiple follow-up psychotherapy “integration” sessions. Researchers have administered psilocybin and LSD to patients for the treatment of depression and major depressive disorder over a period of 6 to 8 weeks. The intensive nature of classic psychedelic therapies raises concerns about their implementation in the real world, where affordability is vital. A proof-of-concept study was developed to evaluate the safety, tolerability, pharmacokinetics, and subjective effects of 50 to 100 g LSD base among healthy participants.

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Perceptions of safety, subjective effects, and beliefs about the clinical utility of lysergic acid diethylamide in healthy participants within a novel intervention paradigm: Qualitative results from a proof-of-concept study

https://doi.org/10.1177%2F02698811211055855

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Study details

Compounds studied
LSD

Topics studied
Neuroscience

Study characteristics
Open-Label Interviews

Participants
31 Humans

Institutes

Institutes associated with this publication

Eleusis
Eleusis is a clinical-stage life sciences company that studies and develops psychedelic drugs for therapeutic use. Since 2013 the company has been researching psychedelics and is now developing ELE-Psilo (psilocybin) for depression that is in Phase I.