©2022 Stanford Medicine
Stanford Regulating Circuits of the Brain Study - MDMA
Trial ID: NCT04060108
This study is a biomarker study designed to characterize how MDMA impacts the reward circuits of the human brain.
Mapping the Influence of Drugs of Abuse on Risk and Reward Circuits - MDMA
1. Ages 18-55
2. Able to swallow capsules
3. All genders and ethno-racial categories
4. Able and willing to enroll and provide written informed consent.
5. Able to comply with study procedures.
6. 2+ prior uses of MDMA when aged 18 years or older and have reported no serious adverse
reactions from MDMA or ecstasy.
7. Non-nicotine user, defined as no primary nicotine exposure for last six months.
8. Agree to not use caffeine for 12 hours before and 10 hours after drug administration.
9. Not using 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).
10. Must agree to inform the investigators within 48 hours of any changes in medical
conditions or procedures.
11. If of childbearing potential, must have a negative pregnancy test at study entry and
prior to each drug session and must agree to use adequate birth control through 10
days after the last drug session. Adequate birth control methods include intrauterine
device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a
barrier contraception, vasectomized sole partner, or double barrier contraception. Two
forms of contraception are required with any barrier method or oral hormones.
12. Able to receive an MRI.
1. Have current serious suicide risk, as determined through psychiatric interview,
responses to C-SSRS, and clinical judgment of the investigator.
2. Current psychiatric, mood, anxiety, eating or psychotic disorder assessed at screening
with the MINI and medical history.
3. 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).
4. 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; or have used Ecstasy (material represented as containing MDMA) more than 10
times within the last 10 years.
5. Positive for drug, or alcohol abuse disorders as assessed through DAST, CUDIT-R,
Fagerstrom and AUDIT measures.
6. Positive test on urine drug screen for illicit and/or drugs of abuse at screening and
prior to study drug administration.
7. 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).
8. 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.
9. Current use of any opioids, including codeine, hydrocodone, and morphine.
10. Have an exclusionary metal device (e.g., presence of metallic device or dental braces,
which are contraindications for MRI) as determined by the discretion of the Clinical
11. BMI outside of healthy range (18-30)
12. Inability to speak, read or understand English at a 5th grade level or severe hearing
13. Plan to move out of the area during the study period (given repeated testing sessions)
14. Individuals who are pregnant or nursing.
15. Schizophrenia in a first degree relative.
16. Direct physical access to or routinely handling of addicting drugs in the regular
course of work duties.
17. Allergy or hypersensitivity to MDMA
18. Renal/hepatic impairment (assessed via laboratory tests during initial screening
19. Hypertension (Hypertension, Stage 1 as defined by a systolic blood pressure >140 mmHg
or diastolic blood pressure > 90 mmHg on two of three measurements at least 15 minutes
apart at initial screening appointment; systolic blood pressure >155 mmHg or diastolic
blood pressure >99 mmHg on two of three measurements at least 15 minutes apart during
drug administration visits)
20. Heart rate <50bpm or >150bpm assessed at initial screening visit (PI discretion for
21. Chronic congestive heart failure, tachyarrhythmias, myocardial ischemia (assessed via
EKG at initial screening appointment)
22. Have a marked Baseline prolongation of QT/QTc interval e.g., repeated demonstration of
a QTc interval >450 milliseconds (ms) in males and >460 ms in females. For transgender
or non-binary participants, QTc interval will be evaluated based on sex assigned at
birth, unless the participant has been on hormonal treatment for 5 or more years.
23. Have evidence or history of significant (controlled or uncontrolled) hematological,
endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal,
gastrointestinal, immunocompromising, or neurological disease, including seizure
disorder, or any other medical disorder judged by the investigator to significantly
increase the risk of MDMA administration (participants with hypothyroidism who are on
adequate and stable thyroid replacement will not be excluded). Note: if participants
present with a history of glaucoma, enrollment would be allowed only with the approval
of their ophthalmologist.
24. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure,
hypokalemia, family history of Long QT Syndrome)
25. Have history of hyponatremia or hyperthermia