Clinical TrialInterpersonal Functioning & Social ConnectednessMDMAPlaceboPlaceboPlaceboUnknown status

MDMA and prosocial behavior

Randomised, double-blind, crossover study (n=18) with four single-dose sessions (MDMA 75 mg; oxytocin 32 IU; MDMA 75 mg + Visken 20 mg; placebo) to investigate oxytocin and 5-HT1A modulation of MDMA-induced prosocial behaviour.

Target Enrollment
18 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind
Registry
NTR / NL2518

Detailed Description

This within-subject, double-blind crossover study in 18 recreational MDMA users assesses prosocial behaviour across four test days separated by a minimum 7-day washout.

Primary outcomes are performance on empathy and social interaction computer tasks and treatment and oxytocin concentrations in blood; secondary measures include a control word-learning task. Each test day includes treatment administration and blood sampling.

Hypotheses: oxytocin will mimic MDMA’s prosocial effects and 5-HT1A blockade will attenuate MDMA-induced prosocial effects; genotype (SERT) may moderate responses.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Crossover

experimental

Within-subject four-condition crossover (MDMA, oxytocin, MDMA+Visken, placebo).

Interventions

  • MDMA75 mg
    via Oral• single dose

    Single oral MDMA 75 mg.

  • Placebo
    via Other• single dose

    Syntocinon (oxytocin) 32 IU intranasal.

  • Placebo75 mg
    via Oral• single dose

    MDMA 75 mg combined with Visken (pindolol) 20 mg oral.

  • Placebo
    via Oral• single dose

    Placebo.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • 1. Experience with MDMA (2–100 lifetime uses, and at least once in the past 12 months).
  • 2. Age 18–40 years.
  • 3. Free from medication (except oral contraception).
  • 4. Good physical health by exam and labs.
  • 5. No major medical, endocrine or neurological condition.
  • 6. BMI 18–28 kg/m2.
  • 7. Written informed consent.
  • 8. Native Dutch speaker (some tasks require this).

Exclusion Criteria

  • 1. History of drug abuse (other than MDMA) or addiction.
  • 2. Women who are pregnant or lactating.
  • 3. Cardiovascular abnormalities on 12-lead ECG.
  • 4. Excessive alcohol use (>20 drinks/week).
  • 5. Hypertension (diastolic >100 or systolic >170 mmHg).
  • 6. Current or history of psychiatric disorder.

Study Details

Locations

Netherlands

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