Clinical TrialHealthy VolunteersMDMAPlaceboRecruiting

MDMA, Cortisol and Memory

Double-blind, placebo-controlled, randomised crossover study (n=60) testing single-dose MDMA (75 mg) and metyrapone (750 mg) versus placebo in ecstasy users to assess memory performance and cortisol responses.

Target Enrollment
60 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind
Registry
NTR / NL1362

Detailed Description

This within-subject crossover trial enrols 60 experienced or novice ecstasy users (30 novice, 30 heavy) to examine the role of cortisol in MDMA-induced memory impairment under four treatment conditions.

Participants receive metyrapone or placebo as pre‑treatment followed one hour later by MDMA 75 mg or placebo; cognitive testing occurs ~90 minutes after MDMA, with saliva sampling for cortisol. Primary outcomes are cognitive and neuroendocrine measurements.

Study Protocol

Preparation

sessions

Dosing

4 sessions
270 min each

Integration

sessions

Study Arms & Interventions

Crossover conditions

experimental

Within-subject, double-blind crossover with four treatment days (Placebo+Placebo; Placebo+MDMA; Metyrapone+Placebo; Metyrapone+MDMA).

Interventions

  • MDMA75 mg
    via Oral• single dose• 1 doses total

    MDMA 75 mg given at 10:30 on each test day (≈90 minutes before cognitive testing).

  • Compound750 mg
    via Oral• single dose• 1 doses total

    Metyrapone 750 mg pre-treatment given ~60 minutes before MDMA/placebo.

  • Placebo
    via Oral• single dose• 1 doses total

    Placebo matching MDMA or metyrapone as per condition.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 1. Experience with the use of MDMA (novice: ≤10 lifetime exposures; heavy: ≥100 lifetime exposures; at least one use in past 12 months for both groups).
  • 2. Free from medication.
  • 3. Good physical health as determined by examination and laboratory analysis.
  • 4. Absence of any major medical (except OAC), endocrine or neurological condition.
  • 5. Normal weight: BMI between 18 and 28 kg/m2.
  • 6. Written informed consent.

Exclusion Criteria

  • 1. History of drug abuse (other than MDMA) or addiction.
  • 2. Women: pregnancy or lactation; not using oral contraceptive pill.
  • 3. Cardiovascular abnormalities on standard 12‑lead ECG.
  • 4. Excessive drinking (>20 alcoholic consumptions per week).
  • 5. Hypertension (diastolic >100 mmHg or systolic >170 mmHg).
  • 6. Current or history of psychiatric disorder.

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2008-11-01
    End: 2012-01-01
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Netherlands

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