Drug Effects on Interpersonal Interaction

Early Phase 1

Completed

• Conditions: Interaction, Social
• Interventions: Drug: MDMA; Drug: placebo oral tablet

• Registration Number: NCT05123716
• Lead Sponsor: University of Chicago

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.

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 Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-17
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: MDMA Then Placebo	placebo oral tablet	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.
Experimental: Placebo Then MDMA	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.
Experimental: Placebo Then MDMA	placebo oral tablet	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.
Experimental: MDMA Then Placebo	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.

Primary Outcome Measures

Name	Time	Method
Profile of Mood States	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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States