There has recently been a renewal of human research with classical hallucinogens (psychedelics). This paper first briefly discusses the unique history of human hallucinogen research, and then reviews the risks of hallucinogen administration and safeguards for minimizing these risks. Although hallucinogens are relatively safe physiologically and are not considered drugs of dependence, their administration involves unique psychological risks. The most likely risk is overwhelming distress during drug action ('bad trip'), which could lead to potentially dangerous behaviour such as leaving the study site. Less common are prolonged psychoses triggered by hallucinogens. Safeguards against these risks include the exclusion of volunteers with personal or family history of psychotic disorders or other severe psychiatric disorders, establishing trust and rapport between session monitors and volunteer before the session, careful volunteer preparation, a safe physical session environment and interpersonal support from at least two study monitors during the session. Investigators should probe for the relatively rare hallucinogen persisting perception disorder in follow-up contact. Persisting adverse reactions are rare when research is conducted along these guidelines. Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science.

/pdf/human-hallucinogen-research-guidelines-for-safety-mhj3st2ktn.pdf

Human hallucinogen research: guidelines for safety.

Lysergic acid diethylamide (LSD) was synthesized in 1938 and its psychoactive effects discovered in 1943. It was used during the 1950s and 1960s as an experimental drug in psychiatric research for producing so-called "experimental psychosis" by altering neurotransmitter system and in psychotherapeutic procedures ("psycholytic" and "psychedelic" therapy). From the mid 1960s, it became an illegal drug of abuse with widespread use that continues today. With the entry of new methods of research and better study oversight, scientific interest in LSD has resumed for brain research and experimental treatments. Due to the lack of any comprehensive review since the 1950s and the widely dispersed experimental literature, the present review focuses on all aspects of the pharmacology and psychopharmacology of LSD. A thorough search of the experimental literature regarding the pharmacology of LSD was performed and the extracted results are given in this review. (Psycho-) pharmacological research on LSD was extensive and produced nearly 10,000 scientific papers. The pharmacology of LSD is complex and its mechanisms of action are still not completely understood. LSD is physiologically well tolerated and psychological reactions can be controlled in a medically supervised setting, but complications may easily result from uncontrolled use by layman. Actually there is new interest in LSD as an experimental tool for elucidating neural mechanisms of (states of) consciousness and there are recently discovered treatment options with LSD in cluster headache and with the terminally ill.

/pdf/the-pharmacology-of-lysergic-acid-diethylamide-a-review-36btvkxoq0.pdf

The pharmacology of lysergic acid diethylamide: a review.

The history of research with psychedelic drugs has produced a variety of methods for their use and conflicting claims about results. First came the wave of excitement among experimentalists in the 1950s when it was claimed that lysergic acid diethylamide (LSD) could produce a model psychosis which might be useful in understanding schizophrenia. While this promise was fading, enthusiastic reports about the possibility of LSD as an aid to psychotherapy in the treatment of alcoholism and other psychiatric disorders appeared. All these approaches were represented in 1959 at the first international conference devoted entirely to LSD. 1 Since then, there have been at least five more published proceedings of such conferences on various aspects of psychedelic drugs. 2-6 The most recent conference on various means of producing states of consciousness was sponsored by the Menninger Foundation and the American Association of Humanistic Psychology on April 7 to 11, 1969, in

https://jamanetwork.com/HttpHandlers/ArticlePdfHandler.ashx?journal=JAMA&articleId=354885&pdfFileName=jama_212_11_010.pdf

The experimental use of psychedelic (LSD) psychotherapy.

Background: Despite an increasing body of research highlighting their efficacy to treat a broad range of medical conditions, psychedelic drugs remain a controversial issue among the public and politicians, tainted by previous stigmatisation and perceptions of risk and danger. Objective: This narrative review examines the evidence for potential harms of the classic psychedelics by separating anecdotes and misinformation from systematic research. Methods: Taking a high-level perspective, we address both psychological and psychiatric risks, such as abuse liability and potential for dependence, as well as medical harms, including toxicity and overdose. We explore the evidence base for these adverse effects to elucidate which of these harms are based largely on anecdotes versus those that stand up to current scientific scrutiny. Results: Our review shows that medical risks are often minimal, and that many – albeit not all – of the persistent negative perceptions of psychological risks are unsupported by the currently available scientific evidence, with the majority of reported adverse effects not being observed in a regulated and/or medical context. Conclusions: This highlights the importance for clinicians and therapists to keep to the highest safety and ethical standards. It is imperative not to be overzealous and to ensure balanced media reporting to avoid future controversies, so that much needed research can continue.

https://journals.sagepub.com/doi/pdf/10.1177/02698811211069100

Adverse effects of psychedelics: From anecdotes and misinformation to systematic science

The European Food Safety Authority (EFSA) was asked by the European Commission to deliver a scientific opinion on ergot alkaloids (EAs) in food and feed. EAs are produced by several members within the fungal orders of Hypocreales and Eurotiales. In Europe, Claviceps purpurea is the most widespread Claviceps species within the Hypocreales. A total of 20 558 analytical results for EAs in 1 716 food, 496 feed and 67 unprocessed grain samples were considered in this opinion. Based on the EAs identified in sclerotia of C. purpurea, and recent literature data, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) based its risk assessment on the main C. purpurea EAs, namely ergometrine, ergotamine, ergosine, ergocristine, ergocryptine (which is a mixture of a- and s- isomers), ergocornine, and the corresponding –inine epimers. The CONTAM Panel performed estimates of both chronic and acute exposure for various age groups across European countries. A BMDL10 of 0.33 mg/kg b.w. per day was calculated for the incidence of tail muscular atrophy in a 13-week rat feeding study of ergotamine. This effect was considered representative of the vasoconstrictive effects of EAs and provided a suitable reference point for establishment of a group acute reference dose of 1 µg/kg body weight (b.w.) and a group tolerable daily intake of 0.6 µg/kg b.w. per day. The Panel concluded that whilst the available data do not indicate a concern for any population subgroup, the dietary exposure estimates relate to a limited number of food groups and a possible unknown contribution from other foods cannot be discounted. Estimates of exposure for livestock based on example diets and levels of EAs in cereal grains reported suggest that under normal conditions the risk of toxicosis is low.

Scientific Opinion on Ergot alkaloids in food and feed

Addition of lysergic acid diethylamide to cultured human leukocytes resulted in a marked increase of chromosomal abnormalities. The distribution of chromosome breaks deviated significantly from random, with an accumulation of aberrations in chromosome No. 1. Cytogenetic investigation of a patient extensively treated with this drug over a 4-year period for paranoid schizophrenia showed a similar increase in chromosomal damage.

Chromosomal Damage in Human Leukocytes Induced by Lysergic Acid Diethylamide

DNA synthesis is thought to be confined to a specific segment of interphase (S) preceding cell division and to be completed prior to the onset of either mitosis or meiosis1. Chromosome pairing and crossing over between homologous chromosomes in meiosis are separate events, both of which involve the DNA moiety of the chromosomes. An explanation of these processes in terms of DNA synthesis has only recently been suggested2,3. Hotta et al.4–6 have demonstrated by biochemical techniques that approximately 0.3 per cent of the total DNA complement of the cell is synthesized in the zygonema-pachynema stages of meiotic prophase in lily microsporocytes. We have cytological evidence of a little DNA synthesis during early pachytene stage in the male mouse.

DNA Synthesis during Meiotic Prophase in Male Mice

National Protein and Nucleic Acid Databases

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Chromosomal Damage in Human Leukocytes Induced by Lysergic Acid Diethylamide

DNA Synthesis during Meiotic Prophase in Male Mice

National Protein and Nucleic Acid Databases