Clinical trial

Effects of Familiarity on Prosocial Effects of MDMA

Name

IRB23-0219

Description

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 arms

Trial start

2023-07-21

Estimated PCD

2024-06-01

Trial end

2024-06-01

Status

Recruiting

Phase

Early phase I

Treatment

MDMA

The stimulant MDMA

Arms:

Familiar partner with MDMA, Unfamiliar partner with MDMA

Placebo

Dextrose

Arms:

Familiar partner with placebo, Unfamiliar partner with placebo

Size

Primary endpoint

Natural Language Processing using large language model

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

Facial expression analysis using HUMEAI software

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

Eligibility criteria

Inclusion Criteria: * used MDMA or psychedelic between 1-40 * high school diploma or equivalent * BMI between 19 and 30 * verbal fluency in English Exclusion Criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ESTIMATED'}}

Updated at

2023-08-18

1 organization

1 product

1 drug

2 indications

Organization

University of Chicago

Product

Indication

Indication

Drug