Stanford Regulating Circuits of the Brain Study - MDMA (NCT04060108) | Clinical Trial Compass
CompletedNot Applicable
Stanford Regulating Circuits of the Brain Study - MDMA
United States22 participantsStarted 2021-11-02
Plain-language summary
This study is a biomarker study designed to characterize how human neural circuits and behaviors are modified during altered states induced by MDMA.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ages 18-55
. Able to swallow capsules
. All genders and ethno-racial categories
. Able and willing to enroll and provide written informed consent.
. Able to comply with study procedures.
. 2+ prior uses of MDMA when aged 18 years or older and have reported no serious adverse reactions from MDMA or ecstasy.
. Non-nicotine user, defined as no primary nicotine exposure for last six months.
. Agree to not use caffeine for 12 hours before and 10 hours after drug administration.
Exclusion criteria
. Have current serious suicide risk, as determined through psychiatric interview, responses to C-SSRS, and clinical judgment of the investigator.
. Current psychiatric, mood, anxiety, eating or psychotic disorder assessed at screening with the MINI and medical history.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Facial Expressions of Emotion Task (FEET, nonconscious and conscious) evoked functional activity and connectivity
Timeframe: up to 2 hours after the administration of MDMA or Placebo
. Current use of any psychotropic medication (a wash-out period of 5 half-lives will be required prior to drug visits followed by a 1-week stabilization period, if the participant reports recently discontinuing a psychotropic medication).
. Have used Ecstasy (material represented as containing MDMA) within 6 months of the first study dose; or have previously participated in a MAPS-sponsored MDMA clinical trial.
. Positive for drug, or alcohol abuse disorders as assessed through DAST, CUDIT-R, Fagerstrom and AUDIT measures.
. Positive test on urine drug screen for illicit and/or drugs of abuse at screening and prior to study drug administration.
. Concurrent use of any medication or substance that might increase the risk of participation and/or interact with MDMA (i.e., serotonergic agents, antidepressants, opiates, any drugs with known interactions with Monoamine Oxidase Inhibitors).
. Unable or unwilling to agree to refrain from using any psychoactive substances (i.e., cannabis), supplements (i.e., St. John's Wort, SAMe, 5HTP) and nonprescription medications (i.e., dextromethorphan) starting 1-week prior to study start and for duration of study.