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A Double-blind, Placebo-controlled Study to Evaluate Very Low Dose LSD in Healthy Volunteers Aged 55-75 Years

NCT04421105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-06-09

No results posted yet for this study

Summary

This study was a Phase 1, double-blind, placebo-controlled, randomised study of very low dose LSD. Healthy volunteers aged 55 to 75 years with no use of LSD in the past 5 years were screened within 28 days of randomization. Subjects who met all inclusion and no exclusion criteria and provided written informed consent were randomised a 1:1:1:1 ratio to receive 6 doses of 5 µg, 10 µg, or 20 µg LSD or placebo, at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose of LSD. A total of 48 subjects were enrolled.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Lysergic acid diethylamide (LSD) 5µg

DRUG

Lysergic acid diethylamide (LSD) 10µg

DRUG

Lysergic acid diethylamide (LSD)20 µg

DRUG

Placebo

Sponsors & Collaborators

  • Eleusis Therapeutics

    lead INDUSTRY

Principal Investigators

  • Research and Development Director · Eleusis Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2015-10-30
Completion
2015-11-05

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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 NCT04421105 on ClinicalTrials.gov