Drug Effects on Interpersonal Interaction

Early Phase 1CompletedNCT05123716

University of Chicago30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Interaction, Social

Interventions

MDMADRUG

Participants will be given 100 mg of MDMA

placebo oral tabletDRUG

Participants will be given a placebo capsule that will only contain lactose.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Profile of Mood States

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.

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

Data from ClinicalTrials.gov

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