Clinical TrialHealthy VolunteersMDMAMDMAMDMAMDMAPlaceboCompleted

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

This crossover trial (n=24) investigates the acute effects of R- and S-MDMA compared to racemic MDMA and placebo in healthy subjects.

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

Detailed Description

Randomised, double-blind, triple-masked, five-period crossover in healthy volunteers comparing 125 mg racemic MDMA, 125 mg S-MDMA, 125 mg R-MDMA, 250 mg R-MDMA, and placebo.

Primary aim is basic science: to characterise acute subjective, physiological and neuroendocrine differences between enantiomers and racemate; participants abstain from psychoactives and follow protocol restrictions.

Study Protocol

Preparation

sessions

Dosing

5 sessions

Integration

sessions

Study Arms & Interventions

125 mg MDMA

experimental

Racemic MDMA 125 mg, single oral dose (one period of the crossover).

Interventions

  • MDMA125 mg
    via Oral• single dose

125 mg S-MDMA

experimental

Enantiomeric S-MDMA 125 mg, single oral dose.

Interventions

  • MDMA125 mg
    via Oral• single dose

    S-enantiomer

125 mg R-MDMA

experimental

Enantiomeric R-MDMA 125 mg, single oral dose.

Interventions

  • MDMA125 mg
    via Oral• single dose

    R-enantiomer

250 mg R-MDMA

experimental

Enantiomeric R-MDMA 250 mg, single oral dose.

Interventions

  • MDMA250 mg
    via Oral• single dose

    Higher R-enantiomer dose

Placebo

inactive

Placebo (mannitol) single oral dose.

Interventions

  • Placebo
    via Oral• single dose

    Mannitol placebo

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age between 18 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 double-barrier birth control throughout study participation.
  • 9. Body mass index between 18-29 kg/m2.

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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