A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Study on the Influence of MDMA on Risk and Reward Circuits of the Brain (IUSA4)

The RBRAIN – MDMA study, run by the Stanford Center for Precision Mental Health and Wellness, investigates the effects of MDMA on the brain, cognition, and subjective experiences. In particular, the study aims to demonstrate how brain circuits and individual experiences are affected by MDMA in real-time. Understanding how therapeutic and potential dependence-causing mechanisms work during MDMA use could possibly be used to tailor therapeutic applications of the drug and interventions to address potential dependence. 

Participants will be randomized to the order in which they receive a high dose of MDMA (120mg), a low dose of MDMA (80mg), and a placebo. The study is double-blind; neither the participants nor the researchers know the treatment order to which participants have been assigned. In each of three study visits where a dose is administered, the participants will complete the same tasks. The tools used to measure brain activity and participants’ experiences are functional magnetic resonance imaging (fMRI) brain scans, cognitive assessments, and surveys of drug effects and participants’ moods. During each session, fMRIs will capture activity in participants’ brains, and they will be monitored afterward. Participants will also be asked about secondary effects on their behavior and self-reported experiences.

The study is open for enrollment of healthy volunteers ages 18-55 who live within proximity of Palo Alto, CA, and report two or more prior uses of MDMA. The first participant was enrolled on November 2, 2021.