Clinical TrialMicrodosingLSDPlaceboCompleted

LSD microdosing - A repeated dosing study

This double-blind, randomized trial (n=60) conducted by Maastricht University Department of Psychology and Neurosciences, explores the effects of repeated doses of LSD (15µg) on mood, cognition, and neuroplasticity in healthy volunteers.

Target Enrollment
53 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind
Registry
NTR / NL8736

Detailed Description

Randomized, double-blind, placebo-controlled trial testing repeated low doses of LSD (15 µg) versus placebo in healthy volunteers over a four-week repeated dosing schedule to assess mood and subjective effects.

Secondary outcomes include measures of cognitive performance and changes in neuroplasticity; safety assessments and standard laboratory screening are used to determine eligibility and monitor adverse events.

Study Arms & Interventions

LSD 15 µg

experimental

Repeated low-dose (microdosing) LSD arm, oral administration over a 4-week repeated dosing schedule.

Interventions

  • LSD15 µg
    via Oral• repeated dosing

    15 µg per dose; repeated dosing schedule over 4 weeks.

Placebo

inactive

Matched placebo comparator.

Interventions

  • Placebo
    via Oral• repeated dosing

    Matched placebo, repeated dosing schedule over 4 weeks.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Having had at least one full-psychedelic experience (regular dose) with LSD, psilocybin, ayahuasca, DMT, Salvinorin, Mescaline, MDMA, NBOMe, 2Cs or any other 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 65 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 drinks 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 > 160 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).
  • Prior exposure to False Memories paradigm.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment53 participants
  • Timeline
    Start: 2020-02-03
    End: 2024-07-01
  • Compounds
    LSDPlacebo
  • Topic
    Microdosing

Locations

Netherlands

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