Clinical TrialHealthy VolunteersPsilocybinPlaceboMDMAPlaceboPsilocybinMDMAPlaceboPlaceboRecruiting

Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects (MDMA-Psilo)

Double-blind, placebo-controlled, 4-period crossover study (n=24) testing 20 mg psilocybin and 100 mg MDMA alone and combined in healthy adults to assess subjective and autonomic effects.

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

Detailed Description

This randomised, triple-masked, 4-period crossover study will compare single oral doses of psilocybin (20 mg), MDMA (100 mg), their combination, and double placebo in healthy volunteers to assess acute subjective and autonomic responses.

Outcomes include measures of subjective experience, anxiety, empathy and trust, as well as autonomic measures; the study is designed as basic science to test whether MDMA augments positive and reduces negative acute effects of psilocybin.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

20 mg psilocybin + MDMA placebo

Interventions

  • Psilocybin20 mg
    via Oral• single dose
  • Placebo
    via Oral• single dose

    MDMA placebo

MDMA

experimental

100 mg MDMA + psilocybin placebo

Interventions

  • MDMA100 mg
    via Oral• single dose
  • Placebo
    via Oral• single dose

    Psilocybin placebo

Psilocybin+MDMA

experimental

20 mg psilocybin + 100 mg MDMA

Interventions

  • Psilocybin20 mg
    via Oral• single dose
  • MDMA100 mg
    via Oral• single dose

Placebo

inactive

Psilocybin placebo + MDMA placebo

Interventions

  • Placebo
    via Oral• single dose

    Psilocybin placebo

  • Placebo
    via Oral• single dose

    MDMA placebo

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 48 h after substance administration.
  • 8. Willing to use effective birth control throughout study participation.
  • 9. Body mass index between 18-29 kg/m2.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Chronic or acute medical condition
  • 2. Current or previous major psychiatric disorder
  • 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. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • 5. Illicit substance use (not including cannabis) more than 20 times or any time within the previous month
  • 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.
  • 9. Tobacco smoking (>10 cigarettes/day).
  • 10. Consumption of alcoholic drinks (>15 drinks/week).

Study Details

Locations

University Hospital Basel — Basel, Switzerland

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