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MDMA for Social Interactions (PEM Trial)

Phase < 1
Recruiting
Led By Harriet de Wit
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 during 15 minute test conversation, occurring 1.5 hours after drug administration
Awards & highlights

PEM Trial Summary

This trial will test if taking MDMA with a familiar person has more positive social effects than with a stranger.

Who is the study for?
This trial is for adults with a BMI of 19-30 who have used MDMA or psychedelics at least once but not more than 40 times, have completed high school education, and are fluent in English. People with recent serious mental health diagnoses, high blood pressure, pregnant women, those trying to conceive, individuals on regular medication or with a history of bad reactions to MDMA cannot participate.Check my eligibility
What is being tested?
The study investigates whether MDMA can enhance social bonding when taken around someone familiar versus an unfamiliar person. Participants will receive either MDMA or a placebo without knowing which one they've received to compare the effects on social interactions.See study design
What are the potential side effects?
MDMA may cause side effects like anxiety, headache, nausea, increased heart rate and blood pressure changes. It might also lead to emotional sensitivity and altered sensory perceptions during the trial.

PEM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 15 minute test conversation, occurring 1.5 hours after drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and during 15 minute test conversation, occurring 1.5 hours after drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Facial expression analysis using HUMEAI software
Natural Language Processing using large language model
Secondary outcome measures
Affective touch
Oxytocin
Self-reported feelings of connection using Likert scale conversation questionnaires

PEM Trial Design

4Treatment groups
Experimental Treatment
Group I: Unfamiliar partner with placeboExperimental Treatment1 Intervention
Participant engages in social interaction with 'unfamiliar' partner under placebo
Group II: Unfamiliar partner with MDMAExperimental Treatment1 Intervention
Participant engages in social interaction with 'unfamiliar' partner under MDMA
Group III: Familiar partner with placeboExperimental Treatment1 Intervention
Participant engages in social interaction with 'familiar' partner under placebo
Group IV: Familiar partner with MDMAExperimental Treatment1 Intervention
Participant engages in social interaction with 'familiar' partner under MDMA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
MDMA
2001
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,697 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,816 Total Patients Enrolled
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,743 Total Patients Enrolled

Media Library

MDMA (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05948683 — Phase < 1
Ecstasy Research Study Groups: Unfamiliar partner with placebo, Familiar partner with MDMA, Unfamiliar partner with MDMA, Familiar partner with placebo
Ecstasy Clinical Trial 2023: MDMA Highlights & Side Effects. Trial Name: NCT05948683 — Phase < 1
MDMA (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05948683 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to participate in this testing protocol?

"Recruitment criteria for this trial mandate that participants have a documented history of ecstasy use and are between 18 to 35. This project is intended to recruit 34 individuals in total."

Answered by AI

Is there still space available for enrolment in this research project?

"Evidenced by the clinicaltrials.gov database, this medical trial is actively trying to recruit participants. The study was first announced on July 1st 2023 and its information has been updated as recently as July 7th of that same year."

Answered by AI

What is the expected recruitment rate for this research endeavor?

"Correct. According to clinicaltrials.gov, this trial which was initially posted on July 1st 2023 is currently recruiting volunteers. There are 34 positions available at one location for participation in the study."

Answered by AI

Is the participant age range for this experiment inclusive of individuals older than 25?

"This clinical trial has an age restriction of 18 - 35 years old. As for patients outside this range, there are 5 trials available to those under the legal age and 9 studies open to adults over 65."

Answered by AI

Who else is applying?

What site did they apply to?
University of Chicago
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Prosocial Effects of MDMA
2023. "Prosocial Effects of MDMA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948683.
~3 spots leftby Jun 2024
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