Clinical TrialHealthy VolunteersPlaceboLSDLSDLSDCompleted

Mood Effects of Serotonin Agonists

Randomised, triple-blind, crossover Phase I study (n=80) comparing placebo and three microdoses of LSD (6.5, 13, 26 µg) in healthy volunteers to assess effects on depressed mood.

Target Enrollment
80 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-blind, crossover Phase I study in healthy volunteers (n=80) testing placebo and three single microdoses of LSD (6.5, 13, 26 µg) delivered in solution to assess acute effects on depressed mood (primary purpose: basic science).

Design includes four dosing sessions per participant with washouts; eligibility required age 18–35 and BMI 19–30. Outcomes focus on mood measures in a healthy volunteer sample.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Placebo

inactive

Placebo comparator

Interventions

  • Placebo
    via Oral• single dose

    Solution form

LSD 6.5 µg

experimental

Low microdose LSD (6.5 µg) in solution

Interventions

  • LSD6.5 µg
    via Oral• single dose

    Solution form

LSD 13 µg

experimental

Medium microdose LSD (13 µg) in solution

Interventions

  • LSD13 µg
    via Oral• single dose

    Solution form

LSD 26 µg

experimental

High microdose LSD (26 µg) in solution

Interventions

  • LSD26 µg
    via Oral• single dose

    Solution form

Participants

Ages
18 – 35
Sexes
Male & Female

Inclusion Criteria

  • English fluency
  • High school level education
  • BMI between 19 and 30

Exclusion Criteria

  • Diagnosed medical condition
  • Women who are nursing, pregnant, or plan to become pregnant within 3 months
  • History of psychotic disorder or family history of psychotic disorder

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment80 participants
  • Timeline
    Start: 2018-01-05
    End: 2020-01-05
  • Compounds
    PlaceboLSDLSDLSD
  • Topic
    Healthy Volunteers

Locations

Matthew Bona — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States

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