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

NCT05674669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-01-06

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Lysergic Acid Diethylamide (LSD) 50µg

DRUG

Lysergic Acid Diethylamide (LSD) 75µg

DRUG

Lysergic Acid Diethylamide (LSD) 100µg

DRUG

Placebo/Lysergic Acid Diethylamide (LSD) 75µg

DRUG

Lysergic Acid Diethylamide (LSD) 50µg/75µg

Sponsors & Collaborators

  • Eleusis Therapeutics

    lead INDUSTRY

Principal Investigators

  • Director of Research and Development · Eleusis Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05674669 on ClinicalTrials.gov