Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Drug Effects on Interpersonal Interaction

This double-blind, placebo-controlled crossover trial (n=30) investigated the effects of MDMA (100mg) compared to placebo on feelings of closeness and mood in semi-structured dyadic conversations.

Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Paired-partner, within-subject design with three sessions: MDMA+conversation with Person A, placebo+conversation with Person B, and a post-test online session assessing partner preference; drug/placebo order counterbalanced and partners same-sex.

Primary outcomes are self-rated feelings of closeness and connection after each drug session and at the online test; participants are fully debriefed after study completion.

Study Protocol

Preparation

sessions

Dosing

2 sessions
45 min each

Integration

sessions

Study Arms & Interventions

MDMA vs placebo

experimental

Within-subject crossover: MDMA (100 mg) and placebo in counterbalanced order; 45-min semi-structured dyadic conversation.

Interventions

  • MDMA100 mg
    via Oralsingle dose1 doses total

    Single 100 mg oral MDMA session; order counterbalanced.

  • Placebo
    via Oralsingle dose1 doses total

    Placebo lactose capsule.

Participants

Ages
1835
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • English fluency
  • High school level education
  • BMI between 19 and 30

Exclusion Criteria

  • Exclusion Criteria:
  • Diagnosed medical condition
  • Women who are nursing, pregnant, or planning pregnancy within 3 months
  • History of psychotic disorder or family history of psychotic disorder

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2021-08-01
    End: 2022-05-01
  • Compounds
  • Topic

Locations

University of ChicagoChicago, Illinois, United States

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