Drug Effects on Interpersonal Interaction

NCT05123716 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB21-0778
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Interaction, Social

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental: Placebo Then MDMA

EXPERIMENTAL

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: MDMA; Drug: placebo oral tablet

Experimental: MDMA Then Placebo

EXPERIMENTAL

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: MDMA; Drug: placebo oral tablet

Interventions

MDMA DRUG

Participants will be given 100 mg of MDMA

Experimental: MDMA Then Placebo; Experimental: Placebo Then MDMA

placebo oral tablet DRUG

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

Experimental: MDMA Then Placebo; Experimental: Placebo Then MDMA

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: August 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

US (1)