NCT05948683

Brief Summary

In this study, the aim is to test the hypothesis that MDMA produces greater prosocial effects when administered in the presence of a familiar, compared to an unfamiliar, person

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jul 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

July 21, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

June 30, 2023

Last Update Submit

August 15, 2024

Conditions

MDMA ('Ecstasy')Social Interaction

Outcome Measures

Primary Outcomes (2)

  • Natural Language Processing using large language model

    Differences in speech content across all conditions

    during 15 minute test conversation, occurring 1.5 hours after drug administration

  • Facial expression analysis using HUMEAI software

    Changes in emotional expressions during conversations

    during 15 minute test conversation, occurring 1.5 hours after drug administration

Secondary Outcomes (3)

  • Oxytocin

    120 minutes post drug administration

  • Self-reported feelings of connection using Likert scale conversation questionnaires

    Collected at the end of the session, 240 minutes post-drug administration

  • Affective touch

    Post-drug, 2 hours post-drug administration

Study Arms (4)

Familiar partner with placebo

EXPERIMENTAL

Participant engages in social interaction with 'familiar' partner under placebo

Drug: Placebo

Familiar partner with MDMA

EXPERIMENTAL

Participant engages in social interaction with 'familiar' partner under MDMA

Drug: MDMA

Unfamiliar partner with placebo

EXPERIMENTAL

Participant engages in social interaction with 'unfamiliar' partner under placebo

Drug: Placebo

Unfamiliar partner with MDMA

EXPERIMENTAL

Participant engages in social interaction with 'unfamiliar' partner under MDMA

Drug: MDMA

Interventions

MDMADRUG

The stimulant MDMA

Familiar partner with MDMAUnfamiliar partner with MDMA
PlaceboDRUG

Dextrose

Familiar partner with placeboUnfamiliar partner with placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • used MDMA or psychedelic between 1-40
  • high school diploma or equivalent
  • BMI between 19 and 30
  • verbal fluency in English

You may not qualify if:

  • History of adverse effects with MDMA
  • High blood pressure
  • Any medical condition requiring regular medication
  • Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
  • Women who are pregnant or trying to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

AmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Harriet de Wit

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 17, 2023

Study Start

July 21, 2023

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

August 19, 2024

Record last verified: 2023-08

Locations

US(1)