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MDMA for Social Interactions (DEI Trial)

Phase < 1
Waitlist Available
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: baseline-72 hours after completion of the sessions
Awards & highlights

Summary

This trial involves participants taking MDMA, a drug that can make people feel more connected. They will have conversations with different partners under each condition. The study aims to see if MDMA makes people feel closer to their conversation partners. MDMA, also known as 3,4-methylenedioxymethamphetamine, has been studied for its potential therapeutic effects, particularly in psychotherapy settings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: baseline-72 hours after completion of the sessions
This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: baseline-72 hours after completion of the sessions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Profile of Mood States

Side effects data

From 2018 Phase 1 & 2 trial • 12 Patients • NCT02876172
33%
Anxiety
17%
Insomnia
17%
Visual Impairment
17%
Vomiting
17%
Upper respiratory tract infection
17%
Arthropod bite
17%
Disturbance in attention
17%
Dizziness
17%
Paresthesia
17%
Nasal congestion
17%
Dyspnoea
17%
Oropharyngeal pain
17%
Rhinorrhoea
17%
Pruritis
17%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSO Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)
PTSD Patients at 6-month Follow-up
CSO Patients at 6-month Follow-up
PTSD Patients Open-label CBCT and MDMA-assisted Therapy (up to 2 Months Post Last Experimental Dose)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Experimental: Placebo Then MDMAExperimental Treatment2 Interventions
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 II: Experimental: MDMA Then PlaceboExperimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
MDMA
2023
Completed Phase 2
~420
placebo oral tablet
2021
Completed Early Phase 1
~190

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,034 Previous Clinical Trials
753,664 Total Patients Enrolled
1 Trials studying Social Interactions
33 Patients Enrolled for Social Interactions
~7 spots leftby Sep 2025
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