Drug Effects on Interpersonal Interaction

MDMA

Brief Summary

The investigators propose to use a Paired Partner design, in which subjects engage in a 45-min semi-structured conversation with one (novel) partner under the influence of MDMA and with another partner under the influence of placebo. At the end of each session, they will rate their feelings about the partner, and on the test day, subjects will be asked which partner they preferred and felt closer to.

Intervention / Treatment

  • MDMA (DRUG)
    Participants will be given 100 mg of MDMA
  • Placebo oral tablet (DRUG)
    Participants will be given a placebo capsule that will only contain lactose.

Condition or Disease

  • Interaction, Social

Phase

  • Early Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 35 Years
    Enrollment: 30 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2021 ACTUAL
    Primary Completion: May 01, 2022 ACTUAL
    Completion Date: May 01, 2022 ACTUAL
    Study First Posted: Nov 17, 2021 ACTUAL
    Last Updated: Jun 10, 2022

    Sponsors / Collaborators

    Lead Sponsor: University of Chicago
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Chicago, Illinois, USA

    The study will use a within-subject design with three sessions: i) MDMA and conversation with Person A, ii) placebo and conversation with Person B, iii) test session (online) assessing preference for Persons A and B. The MDMA dose will be 100 mg, administered under double blind conditions. The conversation will consist of a 45 min dialog between the participant and the partner, a person trained to engage in conversation for this purpose. The dyad will be provided with topics to discuss, at their own pace. The order of administration of drug and placebo will be counterbalanced, and the partners will be same-sex and varied across sessions. The primary outcome measures will be feelings of closeness and connection at the end of the two drug sessions, at the online test session and follow-up. After study completion, participants will be fully informed about the study.

    Participant Groups

    • Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive 100 mg MDMA.

    • Participants first receive 100 mg MDMA at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 35
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * English fluency
    * High school level education
    * BMI between 19 and 30

    Exclusion Criteria:

    * Diagnosed medical condition
    * women who are nursing, pregnant, or plan to become pregnant within 3 months
    * History of psychotic disorder or family history of psychotic disorder

    Primary Outcomes

    • The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.

    More Details

    NCT Number: NCT05123716
    Acronym: DEI
    Other IDs: IRB21-0778
    Study URL: https://clinicaltrials.gov/study/NCT05123716
    Last updated: Sep 29, 2023