Clinical TrialHealthy VolunteersLSDLSDCompleted

Effects of LSD on Neuroplasticity in Healthy Subjects

Randomised, quadruple-blind, placebo-controlled crossover study (n=45) testing single oral high (100 µg) versus low dose LSD in healthy volunteers to assess effects on neuroplasticity.

Target Enrollment
45 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

LSD is a potent psychoplastogen shown to rapidly stimulate neuroplasticity in animal models, but direct evidence in humans is limited. This study investigates whether single doses of LSD enhance measures of cortical plasticity and related cognitive and emotional traits in healthy adults.

The trial uses a randomised, quadruple-blind, placebo-controlled crossover design comparing a high single oral dose (100 µg) and a low single oral dose; outcomes include neurophysiological and neuroimaging measures of plasticity, and behavioural and self-report assessments over follow-up.

Healthy volunteers aged 21–55 are enrolled at the University of Fribourg; the registry reports an actual enrolment of 45 participants.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

High-dose LSD

experimental

High single oral dose of LSD; crossover vs low dose.

Interventions

  • LSD100 µg
    via Oral• single dose

    100 µg LSD base; single dosing session.

Low-dose LSD

active comparator

Low single oral dose of LSD; active comparator in crossover.

Interventions

  • LSD
    via Oral• single dose

    Low dose of LSD base (dose not specified in registry fragment).

Participants

Ages
21 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Aged 21-55
  • 2. Body mass index 18-29
  • 3. Right-handed as assessed by the Edinburgh Handedness Inventory (score > 60)
  • 4. Fluent understanding of German
  • 5. Willingness to adhere to study protocol
  • 6. Willingness to refrain from taking illicit psychoactive substances for the duration of the study
  • 7. Willingness to refrain from consuming alcohol for 24 hours before each study appointment.
  • 8. Willingness to not operate a motor vehicle or other heavy machinery 48 hours after each substance administration.
  • 9. Women of childbearing potential must be willing to use effective birth control during the study (e.g. birth control pill; condoms must be combined with a second reliable method).
  • 10. Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests will be repeated before each treatment day and must remain negative.
  • 11. A friend or relative must be available to accompany the participant home following LSD appointments.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Severe chronic or acute medical condition
  • 2. History of any seizure disorder, stroke, or cardiovascular illness
  • 3. History of severe head trauma resulting in loss of consciousness
  • 4. Personal or family history (first-degree relative) of psychotic disorders
  • 5. Current or previous major neurological or psychiatric disorder within the last 3 years (e.g. major depression, anorexia, substance use disorder)
  • 6. History of medically relevant suicide attempts
  • 7. Current use of psychoactive medications
  • 8. Lifetime use of hallucinogens, dissociatives, or entheogens more than 10 times, or any time within the previous three months
  • 9. Regular (daily or near-daily) use of cannabis, alcohol, nicotine, or illicit substances
  • 10. Pregnant or nursing women
  • 11. Presence of any implanted, metal or electronic devices (e.g. pacemaker)
  • 12. Recent or current participation in another clinical trial

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment45 participants
  • Timeline
    Start: 2022-05-02
    End: 2024-12-01
  • Compounds
    LSDLSD
  • Topic
    Healthy Volunteers

Locations

University of Fribourg — Fribourg, Canton of Fribourg, Switzerland

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