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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: baseline-72 hours after completion of the sessions

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%

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