Drug Effects on Interpersonal Interaction

NCT ID: NCT05123716

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-05-01

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.

Conditions

Interaction, Social

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

MDMA

Intervention Type: DRUG

Participants will be given 100 mg of MDMA

placebo oral tablet

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

MDMA

Intervention Type: DRUG

Participants will be given 100 mg of MDMA

placebo oral tablet

Intervention Type: DRUG

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

Interventions

MDMA

Participants will be given 100 mg of MDMA

Intervention Type: DRUG

placebo oral tablet

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

IRB21-0778

Identifier Type: -

Identifier Source: org_study_id