Clinical TrialHealthy VolunteersPlaceboLSDCompleted

The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers

Randomised, double-blind, placebo-controlled crossover fMRI study (n=25) testing single 100 µg oral LSD vs placebo and ketanserin (40 mg pretreatment) in healthy volunteers to probe 5-HT2A receptor contributions to self and personal meaning.

Target Enrollment
25 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

This randomised, double-blind, placebo-controlled, cross-over trial in 25 healthy volunteers assesses the effects of single-dose oral LSD (100 µg) on self-consciousness, perception and meaning-making using functional magnetic resonance imaging, psychometric and cognitive measures.

The study includes a ketanserin pretreatment condition (40 mg) to evaluate the contribution of the 5-HT2A receptor; sessions use matched placebo capsules and standardised washout, with outcomes including neuroimaging correlates and behavioural/psychometric assessments.

Study Arms & Interventions

LSD crossover

experimental

Randomised, double-blind, placebo-controlled crossover with placebo, LSD (100 µg) and ketanserin (40 mg) conditions.

Interventions

  • Placebo
    via Oral• single dose

    Mannitol placebo capsule, per os

  • LSD100 µg
    via Oral• single dose

    Single 100 µg LSD dose per session

  • Compound40 mg
    via Oral• single dose

    Ketanserin 40 mg given as pretreatment (identical-appearing capsule)

Participants

Ages
20 – 40
Sexes
Male & Female

Inclusion Criteria

  • Healthy male and female volunteers aged 20-40
  • Willing and capable to give informed consent
  • Willing to refrain from alcohol and caffeinated drinks on testing days and from psychoactive substances 2 weeks before testing and for study duration
  • Able and willing to comply with study requirements
  • MRI-compatible body shape and size (BMI 17-30)
  • Right-handedness

Exclusion Criteria

  • Poor knowledge of German
  • Previous significant adverse response to a hallucinogenic drug
  • Participation in another study with pharmaceuticals within 30 days
  • Self or first-degree relatives with present or antecedent psychiatric disorders
  • Present or antecedent alcohol/drug dependence or current alcohol/drug abuse
  • History of head trauma, fainting, seizures, or ECT
  • Recent cardiac or brain surgery
  • Current use of medication known to affect brain function (e.g., benzodiazepines, antihistamines, aspirin, beta blockers, theophylline, acetazolamide, etc.)
  • Concomitant therapy with potent CYP3A4 inhibitors
  • Major internal or neurological disorders
  • Presence of psychiatric disorder
  • Cardiovascular disease (hypertension, coronary artery disease, heart insufficiency, recent MI, coronary spasm)
  • Peripheral vascular disease
  • Liver or renal disease
  • Pregnant or breastfeeding women
  • Inability to lie still for ~60 minutes
  • Metal parts in the body or implanted devices
  • Claustrophobia

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment25 participants
  • Timeline
    Start: 2015-01-03
    End: 2016-01-01
  • Compounds
    PlaceboLSD
  • Topic
    Healthy Volunteers

Locations

Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich — Zurich, Switzerland

Your Library