Clinical TrialHealthy VolunteersPlaceboMDMAPlaceboMDMACompleted

Prosocial Effects of MDMA (PEM)

Early Phase I randomised crossover study (n=33 actual) testing whether MDMA (100 mg) produces greater prosocial effects when administered with a familiar versus unfamiliar partner in healthy volunteers.

Target Enrollment
33 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

This randomised, triple-masked crossover study tests whether MDMA (100 mg) increases prosocial effects more when a participant interacts with a familiar partner than an unfamiliar one.

Familiarity is induced using a 45-minute structured conversation task (deep-talk versus small-talk) shown to increase feelings of closeness; after drug or placebo participants engage in a 15-minute conversation with the familiar or unfamiliar partner.

Outcomes assess prosocial mood and socio-emotional function; the study is a mechanistic laboratory investigation in healthy volunteers rather than a psychotherapy trial.

Study Protocol

Preparation

sessions

Dosing

4 sessions
15 min each

Integration

sessions

Study Arms & Interventions

Familiar + Placebo

inactive

Participant interacts with a familiar partner after placebo.

Interventions

  • Placebo
    via Oral• single dose

    Dextrose placebo

Familiar + MDMA

experimental

Participant interacts with a familiar partner after MDMA 100 mg (single dose).

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total

Unfamiliar + Placebo

inactive

Participant interacts with an unfamiliar partner after placebo.

Interventions

  • Placebo
    via Oral• single dose

    Dextrose placebo

Unfamiliar + MDMA

experimental

Participant interacts with an unfamiliar partner after MDMA 100 mg (single dose).

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total

Participants

Ages
18 – 35
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • used MDMA or psychedelic between 1-40
  • high school diploma or equivalent
  • BMI between 19 and 30
  • verbal fluency in English
  • age 18–35

Exclusion Criteria

  • Exclusion Criteria:
  • History of adverse effects with MDMA
  • High blood pressure
  • Any medical condition requiring regular medication
  • Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
  • Women who are pregnant or trying to become pregnant.

Study Details

Locations

University of Chicago — Chicago, Illinois, United States

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