Clinical TrialHealthy VolunteersMDMAPlaceboRecruiting

MDMA and prosocial behavior: The role of the 2a-serotonin receptor

Randomised, double-blind, four-way crossover study (n≈20) examining single oral MDMA 75 mg, ketanserin 40 mg, their combination and double placebo to test the role of 5‑HT2A receptors in MDMA-induced prosocial behaviour.

Target Enrollment
20 participants
Study Type
interventional
Design
Randomized, double Blind
Registry
NTR / NL3536

Detailed Description

Randomised, double-blind, four-way crossover in recreational MDMA users comparing MDMA 75 mg, ketanserin 40 mg, the combination, and double placebo; minimum 7‑day washout.

Participants attend four 4h15 sessions with blood sampling and cardiovascular monitoring; primary endpoints are cognitive and affective empathy measured with tasks such as the multifaceted empathy test.

Study Protocol

Preparation

sessions

Dosing

4 sessions
255 min each

Integration

sessions

Study Arms & Interventions

MDMA/ketanserin crossover

experimental

Four-way crossover: MDMA 75 mg; ketanserin 40 mg; MDMA+ketanserin; double placebo.

Interventions

  • MDMA75 mg
    via Oral• single dose

    Single oral MDMA 75 mg.

  • Compound40 mg
    via Oral• single dose

    Ketanserin 40 mg (5‑HT2A blocker) pre-treatment.

  • Placebo
    via Oral• single dose

    Matching placebo / double placebo condition.

Participants

Ages
18 – 35
Sexes
Male & Female

Inclusion Criteria

  • 1. Experience with the use of MDMA (minimum 3, maximum 200 lifetime uses; at least once in the past 12 months) assessed by questionnaire and interview.
  • 2. Age 18–35 years.
  • 3. Free from medication (except oral contraception).
  • 4. Good physical health as determined by examination and laboratory analysis.
  • 5. Absence of any major medical, endocrine or neurological condition.
  • 6. BMI 18–28 kg/m2.
  • 7. Written informed consent.
  • 8. Fluent Dutch speaker (some tasks require this).

Exclusion Criteria

  • 1. History of drug abuse (other than the use of MDMA) or addiction.
  • 2. Current or history of psychiatric disorder.
  • 3. Women: pregnancy or lactation.
  • 4. Cardiovascular abnormalities as indicated by the medical questionnaire and/or standard 12‑lead ECG.
  • 5. Excessive drinking (>20 alcoholic consumptions per week).
  • 6. Hypertension (diastolic >90 mmHg; systolic >140 mmHg).

Study Details

  • Status
    Recruiting
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2013-01-30
    End: 2015-01-01
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Netherlands

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