Clinical TrialHealthy VolunteersMDMAMDMAPlaceboCompleted

Come closer: a neurobiological analysis of the prosocial effects of MDMA

Double-blind, placebo-controlled crossover study (n=24) testing single-dose MDMA (75 mg), intranasal oxytocin (48 IU), MDMA+5-HT1A blocker (pindolol 20 mg), and placebo in healthy MDMA-experienced volunteers to investigate prosocial effects and mechanisms.

Target Enrollment
24 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Randomized, double-blind, placebo-controlled within-subject crossover (Latin square) with four test days separated by a minimum 7-day washout; treatments: MDMA 75 mg oral capsule, MDMA+5-HT1A blocker (pindolol 20 mg), intranasal oxytocin (48 IU total), and placebo.

Outcomes include objective computer tasks of empathy and social interaction, control word-learning task, and blood measurements of MDMA, oxytocin and other treatment concentrations; also assessment of the moderating effect of serotonin transporter genotype.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

MDMA

experimental

Single-dose MDMA 75 mg (oral) as one condition of a 4-condition crossover (Latin square).

Interventions

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

    MDMA 75 mg capsule.

MDMA + pindolol

experimental

MDMA 75 mg with pindolol 20 mg (5-HT1A blocker) as combination condition; crossover.

Interventions

  • MDMA75 mg
    via Oral• single dose• 1 doses total
  • Compound20 mg
    via Oral• single dose

    Pindolol (Visken®) 20 mg capsule, peak ~60 min; given in combination condition.

Oxytocin

experimental

Intranasal oxytocin condition (48 IU total) as one arm of the crossover.

Interventions

  • Compound48 IU
    via Other• single dose• 1 doses total

    Syntocinon® intranasal spray, total 48 IU (multiple inhalations as per protocol).

Placebo

inactive

Matching placebo condition; part of 4-condition crossover.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Matching placebo capsules/sprays for each active condition.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • Healthy volunteers aged 18–40 years who have used ecstasy/MDMA between 3 and 200 times lifetime and at least once in the last year.
  • Informed consent and ability to comply with study procedures.

Exclusion Criteria

  • Never used ecstasy/MDMA.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2011-06-14
    End: 2012-01-01
  • Compounds
    MDMAMDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Netherlands

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