Clinical TrialHealthy VolunteersMDMAPlaceboPlaceboCompleted

Effects of MDMA on Social and Emotional Processing

Within-subjects, double-blind, placebo-controlled study (n=65) testing MDMA (0, 0.75, 1.5 mg/kg, to 125 mg) with oxytocin (20 IU) as an active control in healthy volunteers to assess social and emotional processing.

Target Enrollment
65 participants
Study Type
Phase NA interventional
Design
Non-randomized, double Blind

Detailed Description

Randomised allocation was not used; this is a within-subjects, double-blind, double-dummy experiment in healthy volunteers (n=65) comparing two active MDMA doses, oxytocin 20 IU, and placebo to characterise empathogenic effects.

Primary measures assess emotion recognition, emotional responsiveness and sociability; safety monitoring included ECG and medical screening. MDMA dosing used 0.75 and 1.5 mg/kg (capped at 125 mg).

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Within-subjects

experimental

Within-subjects, double-blind, double-dummy crossover: each participant received MDMA (0, 0.75, 1.5 mg/kg; cap 125 mg), oxytocin (20 IU), and placebo across sessions.

Interventions

  • MDMA1.5 mg/kg
    via Oral• single dose

    Also includes 0.75 mg/kg MDMA sessions and placebo; dose capped at 125 mg.

  • Placebo
    via Other• single dose

    Oxytocin 20 IU (intranasal) used as active control (encoded as placebo reference with note).

  • Placebo
    via Other• single dose

    Placebo sessions (matched double-dummy).

Participants

Ages
18 – 35
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 18-35 years
  • Healthy
  • Normal weight
  • High school education
  • Normal electrocardiogram
  • No psychiatric disorders
  • Occasional MDMA use

Exclusion Criteria

  • Exclusion Criteria:
  • Current medications
  • Night shift work
  • Abnormal electrocardiogram
  • Medical problems

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomizeddouble Blind
  • Target Enrollment65 participants
  • Timeline
    Start: 2010-01-07
    End: 2013-01-03
  • Compounds
    MDMAPlaceboPlacebo
  • Topic
    Healthy Volunteers

Locations

University of Chicago — Chicago, Illinois, United States

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