drugset / Trial / NCT05674669

A Dose-Ranging Study of 50 µg to 100 µg LSD in Healthy Volunteers

NCT05674669

Phase 1 Completed 32 enrolled Eleusis Therapeutics
RandomizedCrossoverQuadruple-blindOther

Summary

This study with low-dose LSD comprised 2 substudies in healthy subjects. Subjects who met all inclusion and no exclusion criteria provided written informed consent. Part 1 was an open-label dose-escalation study in hallucinogen non-naïve subjects with significant prior experience with hallucinogens, during which each subject received a single dose of LSD: 50, 75, or 100 µg. Part 2 was a double blind, placebo controlled, randomised, crossover study in hallucinogen naïve subjects with no prior experience with hallucinogens in the last 7 years, during which each subject was assigned to 1 of 8 cohorts and then randomly assigned to receive single doses of LSD 50 µg followed by 75 µg, or placebo followed by 75 µg, with dosing separated by at least 7 days. Subjects were followed up on the day after each dosing, and 1 week and 1 month after the last dose of study treatment. A total of 32 subjects were enrolled.

Timeline

Start
2015-10-20
Primary completion
2016-07-26
Completion
2017-07-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Lysergic Acid Diethylamide Other / unclassified 50 ug
Subject Lysergic Acid Diethylamide Other / unclassified 75 ug
Subject Lysergic Acid Diethylamide Other / unclassified 100 ug

Indications

No indication recorded.