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OpenTrials
Completed

NCT Number: NCT05123716

Drug Effects on Interpersonal Interaction

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.

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Key information

Conditions

Interaction, Social

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Profile of Mood States

    Time frame: Time Frame: Baseline-72 hours after completion of the sessions

    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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: DEI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2021
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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