Clinical TrialHealthy VolunteersMDMAMDMAPlaceboCompleted

Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose

Phase I triple-blind, random-order, 3-period crossover in healthy volunteers (n=25) comparing MDMA 120 mg + 60 mg booster (2 h), MDMA 120 mg + placebo, and placebo + placebo to assess duration of acute subjective, physiological and endocrine effects.

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

Detailed Description

This basic science study examines acute effects of MDMA in healthy volunteers to compare duration and intensity of subjective, physiological and endocrine responses when a booster dose is given versus no booster and versus placebo.

Subjects undergo three sessions in random order: MDMA 120 mg with a 60 mg booster at 2 hours, MDMA 120 mg with placebo at 2 hours, and placebo with placebo. The design tests whether a booster prolongs acute effects or increases side effects.

Outcomes include acute subjective measures, cardiovascular and thermoregulatory parameters, and endocrine markers; safety and tolerability are monitored throughout each session.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

MDMA + booster

experimental

Initial 120 mg MDMA followed by 60 mg booster at 2 hours.

Interventions

  • MDMA120 mg
    via Oral• two doses (0 h and 2 h)• 2 doses total

    Second dose 60 mg at 2 hours after initial 120 mg.

MDMA only

experimental

120 mg MDMA followed by placebo at 2 hours.

Interventions

  • MDMA120 mg
    via Oral• single initial dose with placebo at 2 h• 1 doses total

    Placebo given at 2 hours.

Placebo

inactive

Placebo at 0 h and placebo at 2 h.

Interventions

  • Placebo
    via Oral• two administrations (0 h and 2 h)

    Oral placebo at both time points.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Good understanding of the German language.
  • 2. Understanding the procedures and the risks that are associated with the study.
  • 3. Participants must be willing to adhere to the protocol and sign the consent form.
  • 4. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • 5. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study day.
  • 6. Participants must be willing not to drive a traffic vehicle or to operate machines within 48h after substance administration.
  • 7. Willing to use effective birth control throughout study participation.
  • 8. Body mass index between 18-29 kg/m2.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Relevant 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. Previous MDMA use 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

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment25 participants
  • Timeline
    Start: 2023-11-17
    End: 2025-12-31
  • Compounds
    MDMAMDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital — Basel, Switzerland

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