Drug Effects on Interpersonal Interaction (DEI)

The University of Chicago

Status and phase: Completed; Early Phase 1

Conditions: Interaction, Social

Treatments: Drug: placebo oral tablet; Drug: MDMA

Study type: Interventional

Funder types: Other

Identifiers

NCT05123716

IRB21-0778

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups

Experimental: Placebo Then MDMA

Experimental group

Description:

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.

Treatment:

Drug: MDMA

Drug: placebo oral tablet

Experimental: MDMA Then Placebo

Experimental group

Description:

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.

Treatment:

Drug: MDMA

Drug: placebo oral tablet