Clinical TrialHealthy VolunteersLSDPlaceboCompleted

Psychological, Physiological, Endocrine, and Pharmacokinetic Effects of LSD in a Controlled Study

Randomised, double-blind, placebo-controlled crossover study (n=16) comparing single 200 µg oral LSD vs placebo in healthy adults to characterise acute physiological, endocrine and pharmacokinetic responses and assess long-term psychological effects.

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

Detailed Description

Randomised, double-blind, placebo-controlled crossover with two experimental sessions per subject (placebo and LSD). Subjective and cardiovascular responses were assessed repeatedly and plasma samples collected for pharmacokinetics and endocrine measurements.

The primary aim was to characterise acute psychological, physiological, endocrine and pharmacokinetic effects of a single 200 µg oral LSD dose in healthy volunteers; long-term psychological changes were also assessed.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Placebo, LSD

experimental

Randomised double-blind placebo-controlled crossover; within-subject placebo and LSD sessions.

Interventions

  • LSD200 µg
    via Oral• single dose• 1 doses total

    Single 200 µg oral LSD session.

  • Placebo
    via Oral• single dose

    Mannitol placebo capsule, identical appearance.

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • 1. Age between 25 and 65 years
  • 2. Understanding of the German language
  • 3. Understanding the procedures and the risks associated with the study
  • 4. Willing to adhere to the protocol and sign the consent form
  • 5. Willing to refrain from taking illicit psychoactive substances during the study
  • 6. Willing to drink only alcohol-free liquids and no xanthine-containing liquids after midnight before the study session and during the study day
  • 7. Willing not to drive a traffic vehicle within 48 hours following LSD administration
  • 8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study and before each study session and agree to use effective contraception.

Exclusion Criteria

  • 1. Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG (in particular: hypertension >150/95 mmHg); personal or first-degree history of seizures; cardiac or neurological disorder
  • 2. Current or previous psychotic or major affective disorder
  • 3. Psychotic or major affective disorder in first-degree relatives
  • 4. Relevant prior illicit drug use (except THC) more than 10 times or any use within the previous 2 months
  • 5. Pregnant or nursing women
  • 6. Participation in another clinical trial currently or within the last 30 days
  • 7. Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
  • 8. Insufficient interpersonal relationship/rapport with study physician as judged by the study physician

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2013-01-06
    End: 2014-01-12
  • Compounds
    LSDPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital Basel — Basel, Canton of Basel-City, Switzerland

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