Clinical TrialHealthy VolunteersLSDPlaceboRecruiting

The effects of three small morning and evening doses of LSD on mood, biological and psychological measures of sleep, neuroplasticity, and well-being

Randomised, double-blind factorial trial (n=24) testing three repeated microdoses of LSD (20 µg; three dosing days) versus placebo in healthy volunteers to assess effects on mood, sleep, neuroplasticity and related biomarkers.

Target Enrollment
24 participants
Study Type
interventional
Design
Randomized, double Blind
Registry
NTR / NL9821

Detailed Description

Randomised, double-blind interventional study in healthy volunteers comparing three repeated morning versus evening microdoses of LSD (20 µg) against placebo in a factorial design; three dosing days are administered with interspersed non-dosing days.

Primary outcome is mood; secondary outcomes include measures of sleep, neuroplasticity (including BDNF and slow-wave sleep), cognitive performance, emotion regulation, markers of well-being, cortisol and endocannabinoid levels.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

LSD 20 µg

experimental

Three repeated microdoses of LSD (20 µg) given on dosing days; factorial design comparing morning vs evening dosing versus placebo.

Interventions

  • LSD20 µg
    via Oral• three doses• 3 doses total
  • Placebo
    via Oral• three doses• 3 doses total

    Matched placebo on same schedule

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Written informed consent
  • Understanding the procedures and the risks associated with the study
  • At least 18 years of age
  • Absence of any major medical condition as determined by medical examination and laboratory analysis
  • Absence of any major psychological condition as determined by medical examination
  • Free from psychotropic medication
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study
  • Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day
  • Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration
  • Participants are asked to not make any substantial changes in their diet
  • Participants must be willing to comply with guidelines regarding their bedtime
  • Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2

Exclusion Criteria

  • History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination)
  • Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks)
  • Pregnancy or lactation
  • Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg)
  • Current or history of psychiatric disorder (determined by the medical questionnaire and medical examination)
  • Psychotic disorder in first-degree relatives
  • Any chronic or acute medical condition
  • History of cardiac dysfunctions (arrhythmia, ischemic heart disease, …)
  • For women: no use of a reliable contraceptive
  • Tobacco smoking (>20 per day)
  • Excessive drinking (>20 alcoholic consumptions per week)
  • Experience with a full dose of a psychedelic within the last three months

Study Details

  • Status
    Recruiting
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2021-12-01
    End: 2024-12-30
  • Compounds
    LSDPlacebo
  • Topic
    Healthy Volunteers

Locations

Netherlands

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