Anxiety DisordersHealthy VolunteersMedicinal Chemistry & Drug DevelopmentLSD

Acute dose-dependent effects of lysergic acid diethylamide in a double-blind placebo-controlled study in healthy subjects

In a double-blind, placebo-controlled crossover study in 16 healthy volunteers, LSD showed dose-proportional pharmacokinetics and produced dose-dependent subjective and autonomic effects from 25 µg, with a ceiling for positive ("good") effects at 100 µg while 200 µg increased ego dissolution, anxiety and duration of effects. Pretreatment with the 5‑HT2A antagonist ketanserin blocked the effects of 200 µg, indicating that LSD's full psychedelic effects are primarily mediated by 5‑HT2A receptor activation and informing dose selection for future research.

Authors

  • Patrick Vizeli
  • Stefan Borgwardt
  • Patrick Dolder

Published

Neuropsychopharmacology
individual Study

Abstract

Growing interest has been seen in using lysergic acid diethylamide (LSD) in psychiatric research and therapy. However, no modern studies have evaluated subjective and autonomic effects of different and pharmaceutically well-defined doses of LSD. We used a double-blind, randomized, placebo-controlled, crossover design in 16 healthy subjects (eight women, eight men) who underwent six 25 h sessions and received placebo, LSD (25, 50, 100, and 200 µg), and 200 µg LSD 1 h after administration of the serotonin 5-hydroxytryptamine-2A (5-HT 2A ) receptor antagonist ketanserin (40 mg). Test days were separated by at least 10 days. Outcome measures included self-rating scales that evaluated subjective effects, autonomic effects, adverse effects, plasma brain-derived neurotrophic factor levels, and pharmacokinetics up to 24 h. The pharmacokinetic-subjective response relationship was evaluated. LSD showed dose-proportional pharmacokinetics and first-order elimination and dose-dependently induced subjective responses starting at the 25 µg dose. A ceiling effect was observed for good drug effects at 100 µg. The 200 µg dose of LSD induced greater ego dissolution than the 100 µg dose and induced significant anxiety. The average duration of subjective effects increased from 6.7 to 11 h with increasing doses of 25–200 µg. LSD moderately increased blood pressure and heart rate. Ketanserin effectively prevented the response to 200 µg LSD. The LSD dose–response curve showed a ceiling effect for subjective good effects, and ego dissolution and anxiety increased further at a dose above 100 µg. These results may assist with dose finding for future LSD research. The full psychedelic effects of LSD are primarily mediated by serotonin 5-HT 2A receptor activation.

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Research Summary of 'Acute dose-dependent effects of lysergic acid diethylamide in a double-blind placebo-controlled study in healthy subjects'

Introduction

Holze and colleagues situate LSD as a classical serotonergic psychedelic that produces complex alterations of consciousness primarily via serotonin 5-HT2A receptor stimulation. Renewed clinical and research interest in LSD has not been matched by modern within-subject data comparing multiple, pharmaceutically well-characterised acute doses in the same participants. The authors note gaps in dose–response knowledge, the need to document plasma exposure (pharmacokinetics, PK) alongside subjective effects, and interest in potential biomarkers of neuroplasticity such as brain-derived neurotrophic factor (BDNF). The study therefore set out to characterise acute subjective, autonomic and biomarker (plasma BDNF) responses to a range of LSD base doses (25, 50, 100 and 200 µg) in healthy volunteers, to define PK-PD relationships, and to test the role of 5-HT2A receptors by administering ketanserin (40 mg) prior to a 200 µg LSD dose. The investigators hypothesised dose-dependent effects that would be blocked by ketanserin and aimed to provide dose-finding data relevant to future research and therapeutic applications.

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Study Details

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