Drug Effects on Interpersonal Interaction (DEI)

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.

Study Overview

• Status: Completed
• Conditions: Interaction, Social
• Intervention / Treatment: Drug: placebo oral tablet; Drug: MDMA

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Placebo Then MDMA; 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.	Drug: placebo oral tablet; Participants will be given a placebo capsule that will only contain lactose.; Drug: MDMA; Participants will be given 100 mg of MDMA
Experimental: Experimental: MDMA Then Placebo; 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.	Drug: placebo oral tablet; Participants will be given a placebo capsule that will only contain lactose.; Drug: MDMA; Participants will be given 100 mg of MDMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Baseline-72 hours after completion of the sessions

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB21-0778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No