Clinical TrialMicrodosingLSDLSDLSDPlaceboNot yet recruiting

LSD microdosing

This interventional trial (n=27), led by Maastricht University with sponsorship from the Department of Psychology and Neurosciences, involves exploring the dose-response relationship in LSD-induced subjective and cognitive effects in healthy volunteers.

Target Enrollment
27 participants
Study Type
interventional
Design
Randomized, double Blind
Registry
NTR / NL6907

Detailed Description

The present study explores the dose-response relationship in LSD-induced subjective and cognitive effects using single low doses of LSD (5, 10, 20 µg) compared to placebo in healthy volunteers.

Randomised, double-blind, placebo-controlled crossover design with four single-dose sessions per participant; outcomes include validated subjective measures and assessment of cognitive performance.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

LSD microdosing

experimental

Randomised, double-blind, placebo-controlled crossover of single low doses of LSD versus placebo.

Interventions

  • LSD5 µg
    via Oral• single dose

    Single low dose (5 µg).

  • LSD10 µg
    via Oral• single dose

    Single low dose (10 µg).

  • LSD20 µg
    via Oral• single dose

    Single low dose (20 µg).

  • Placebo
    via Oral• single dose

    Matched placebo.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • Previous experience with a psychedelic drug, but not within the past 3 months.
  • Proficient knowledge of the English language.
  • Written informed consent.
  • Understanding the procedures and the risks associated with the study.
  • Age between 18 and 40 years.
  • 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.
  • 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).

Study Details

  • Status
    Not yet recruiting
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment27 participants
  • Timeline
    Start: 2018-05-01
    End: 2024-12-30
  • Compounds
    LSDLSDLSDPlacebo
  • Topic
    Microdosing

Locations

Netherlands

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