Stanford Regulating Circuits of the Brain Study - MDMA

Brief Summary

This study is a biomarker study designed to characterize how MDMA impacts the reward circuits of the human brain.

Intervention / Treatment

  • Drug: MDMA

Condition or Disease

  • Healthy

Phase

Study Design

Study type: Observational
Status: Recruiting
Study results: No Results Available
Age: 18 Years to 55 Years   (Adult)
Enrollment: 40 ()
Funded by: Other|NIH

Masking

Clinical Trial Dates

Start date: Nov 02, 2021
Primary Completion: Nov 01, 2024
Completion Date: Nov 01, 2025
Study First Posted: Aug 16, 2019
Results First Posted: Aug 30, 2020
Last Updated: Apr 14, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

The investigators will assess the effect of acute MDMA modulation on the functioning of reward-related human brain circuits. Reward-related brain circuits will be assessed using functional magnetic resonance imaging.

Participants will include volunteers who report more than two prior uses of MDMA (also known as Ecstasy), when they were 18 years or older.

The investigators will recruit individuals who have previously tried MDMA rather than those who are MDMA-naïve.

Participants will receive an oral dose of MDMA (80mg and 120mg) and placebo (saline) at 3 separate study sessions. Following established procedures, these three sessions will be randomized in a blinded protocol in order to limit expectancy effects.

Throughout each session, participants will be monitored. Functional imaging will commence after the drug has reached peak levels, following previously established time courses for MDMA administered orally. Participants will also be monitored after the functional imaging session. Secondary effects of MDMA on behavior and self-reported experience will be assessed.

In the assessment of the acute effects of MDMA, the investigators will take into account the cumulative effects of prior drug exposure.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 55

This clinical trial is recruiting

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More Details

NCT Number: NCT04060108
Acronym: RBRAIN-MDMA
Other IDs: 52244|1P50DA042012-01A1
Study URL: https://ClinicalTrials.gov/show/NCT04060108
Last updated: Jun 16, 2022