Clinical TrialHealthy VolunteersPlaceboPsilocybinPlaceboPsilocybinCompleted

Effects of SERT Inhibition on the Subjective Response to Psilocybin in Healthy Subjects

Randomised, triple-masked, two-period crossover healthy volunteer study (n=27) comparing 14-day escitalopram pretreatment versus placebo before a single oral psilocybin 25 mg session to assess subjective, physiological and gene-expression effects.

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

Detailed Description

Participants undergo two study periods in randomized order: 14 days of escitalopram (10 mg x7 then 20 mg x7) or placebo pretreatment, each followed by a single 25 mg oral psilocybin session.

Primary outcome is subjective effects on consciousness measured by the 5D-ASC total score; secondary outcomes include additional psychological instruments, plasma concentrations of psilocybin and escitalopram, HTR gene expression and safety measures (autonomic effects, ECG).

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Escitalopram pretreatment

experimental

Pretreatment with escitalopram (10 mg x7 days then 20 mg x7 days) followed by single-dose psilocybin 25 mg (oral) on study day.

Interventions

  • Placebo10 - 20 mg
    via Oral• 14-day pretreatment

    Escitalopram 10 mg for 7 days then 20 mg for 7 days (oral) prior to psilocybin session

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Psilocybin 25 mg on study day

Placebo pretreatment

inactive

Pretreatment with placebo (mannitol) x14 days followed by single-dose psilocybin 25 mg (oral) on study day.

Interventions

  • Placebo
    via Oral• 14-day pretreatment

    Placebo (mannitol) oral capsule x14 days prior to psilocybin session

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Psilocybin 25 mg on study day

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age between 25 and 65 years.
  • 2. Understanding of the German language.
  • 3. Understanding the procedures and the risks that are associated with the study.
  • 4. Participants must be willing to adhere to the protocol and sign the consent form.
  • 5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • 6. 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.
  • 7. Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.
  • 8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session.
  • 9. Women of childbearing potential must be willing to use double-barrier birth control.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Chronic or acute medical condition, including a history of seizures.
  • 2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders, and substance abuse).
  • 3. Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
  • 4. Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
  • 5. History of an angle closure glaucoma.
  • 6. Pregnant or nursing women.
  • 7. Participation in another clinical trial (currently or within the last 30 days).
  • 8. Use of medications that may interfere with the effects of the study medications (any psychiatric medications and any medication with known pharmacokinetic or pharmacodynamic interactions with escitalopram).
  • 9. A corrected QT time (QTc), calculated by Bazett's formula, of over 450 milliseconds in males and over 470 milliseconds in females.
  • 10. Tobacco smoking (\>10 cigarettes/day).
  • 11. Consumption of alcoholic drinks (\>10 drinks / week).
  • 12. Bodyweight \< 45 kg.

Study Details

Locations

University Hospital Basel, Clinical Trial Unit — Basel, Canton of Basel-City, Switzerland

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