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Safety, tolerability, PK & PD of low dose LSD in healthy subjects

  • Research type

    Research Study

  • Full title

    A Phase 1, single-centre, dose-escalation study utilising both open-label and double-blind placebo-controlled crossover design studies to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of low doses of lysergic acid diethylamide ranging from 50μg to 100μg in healthy volunteers

  • IRAS ID

    183359

  • Contact name

    Shlomi Raz

  • Contact email

    shlomi.raz@eleusisbenefitcorp.com

  • Sponsor organisation

    Eleusis Benefit Corporation, PBC

  • Eudract number

    2015-003151-21

  • Duration of Study in the UK

    1 years, 4 months, 21 days

  • Research summary

    The medicine being tested in this study is a compound called lysergic acid diethylamide (LSD). Research into the effects of LSD was common in the 1950s and 1960s and since then, very little research has been done. The Sponsor, Eleusis Benefit Corporation PBC, is investigating the therapeutic potential of low dose LSD and its medical applications, particularly its potential use in the treatment of Alzheimer's disease.

    This study is the second in a programme of studies looking at symptom relief and possible disease modifying effects of LSD in Alzheimer's disease. This study will look at the safety, tolerability, pharmacokinetics and pharmacodynamics of low dose LSD in healthy volunteers aged 21-65 years old.

    The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body and excreted (removed from the body).

    A further aim of the study is to look at the possible effects that the study drug has on learning ability, mood, body senses and movement. A number of memory, knowledge, learning, awareness, mood and movement tests will be completed throughout the study in order to assess the cognitive effects of low dose LSD.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    15/LO/1029

  • Date of REC Opinion

    16 Sep 2015

  • REC opinion

    Further Information Favourable Opinion