Clinical TrialHealthy VolunteersMDMAMDMAPlaceboRecruiting

Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants (R-S-)

This randomised, triple-blind, placebo-controlled Phase I crossover trial (n=24) will compare the acute effects of two enantiomers of MDMA—R-MDMA (300 mg) and S-MDMA (100 mg)—in healthy adult participants.

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

Detailed Description

Randomised, triple-blind, placebo-controlled 3-period crossover in healthy volunteers to compare acute subjective and physiological effects of single oral doses of R-MDMA (300 mg) and S-MDMA (100 mg) against placebo.

Primary aim is basic science characterisation of enantiomer-specific pharmacology and subjective effects; outcomes include vital signs, adverse events and standard psychometric instruments.

Each participant receives three single-dose sessions (R-MDMA, S-MDMA, placebo) with washout between periods; estimated enrollment 24 at University Hospital Basel.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

R-MDMA 300mg

experimental

Single oral dose of R-MDMA 300 mg in crossover period.

Interventions

  • MDMA300 mg
    via Oral• single dose

    R-MDMA (300 mg)

S-MDMA 100mg

experimental

Single oral dose of S-MDMA 100 mg in crossover period.

Interventions

  • MDMA100 mg
    via Oral• single dose

    S-MDMA (100 mg)

Placebo

inactive

Placebo (mannitol) comparator in crossover period.

Interventions

  • Placebo
    via Oral• single dose

    Placebo (mannitol)

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age between 18 and 65 years
  • 2. Good understanding of the German language
  • 3. Understanding of procedures and risks associated with the study
  • 4. Willing to adhere to the protocol and signing of the consent form
  • 5. Willing to refrain from the consumption of illicit psychoactive substances during the study
  • 6. Willing not to operate heavy machinery within 48 h after administration of a study substance (including driving a car)
  • 7. Willing to use effective birth-control throughout study participation.
  • 8. Body mass index 18 - 34.9 kg/m2

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Relevant chronic or acute medical condition
  • 2. Current or previous major psychiatric disorder (e.g. bipolar disorder, schizophrenia), current depression or anxiety disorder
  • 3. Psychotic disorder or bipolar disorder in first-degree relatives
  • 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. Pregnancy or current breastfeeding
  • 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 medication
  • 9. Tobacco smoking (>10 cigarettes/day).
  • 10. Excessive consumption of alcoholic beverages (>15 drinks/week)

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2025-05-01
    End: 2026-11-01
  • Compounds
    MDMAMDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

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

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