Stanford Regulating Circuits of the Brain Study - MDMA

NCT04060108 | Completed DMC FDA Drug

• 2 other identifiers: 522441P50DA042012-01A1
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a biomarker study designed to characterize how human neural circuits and behaviors are modified during altered states induced by MDMA.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Facial Expressions of Emotion Task (FEET, nonconscious and conscious) evoked functional activity and connectivity

  For the non-conscious task, participants are shown a series of faces, presented in pairs. The first face in each pair is presented for only a fraction of a second and may be hard to see. Participants press a button every time they see a face. For the conscious task, participants do the same thing same but with a new set of faces.

  up to 2 hours after the administration of MDMA or Placebo

Secondary Outcomes (22)

• Resting-state functional activity and connectivity

  up to 2 hours after the administration of MDMA or Placebo

• MID evoked functional activity and connectivity

  up to 2 hours after the administration of MDMA or Placebo

• Go-No-Go evoked functional activity and connectivity

  up to 2 hours after the administration of MDMA or Placebo

• Behavioral responses on the WebNeuro computerized test battery assessing cognitive capacity

  up to 5 hours after the administration of MDMA or Placebo

• Self-reported responses as assessed by the 21-item Depression, Anxiety and Stress Scale (DASS)

  up to 5 hours after the administration of MDMA or Placebo

Study Arms (1)

MDMA Within Subject Cross-over

Participants will be randomized to high-dose, low-dose, or placebo for each of the the three study sessions.

Drug: MDMA

Interventions

MDMA DRUG

80mg, 120mg, Placebo

Also known as: 3,4-Methyl enedioxy methamphetamine, ecstasy

MDMA Within Subject Cross-over

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participants ages 18-55 years who have had at least two prior exposures to MDMA

You may qualify if:

• 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.
• + 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.
• 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).
• Must agree to inform the investigators within 48 hours of any changes in medical conditions or procedures.
• 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.
• Able to receive an MRI.

You may not qualify if:

• 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.
• 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.
• Current use of any opioids, including codeine, hydrocodone, and morphine.
• BMI outside of healthy range (18-30)
• Inability to speak, read or understand English at a 5th grade level or severe hearing impairment.
• Plan to move out of the area during the study period (given repeated testing sessions)
• Individuals who are pregnant or nursing.
• Schizophrenia in a first degree relative.
• Direct physical access to or routinely handling of addicting drugs in the regular course of work duties.

Sponsors & Collaborators

• Lykos Therapeutics: collaborator
• Stanford University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford Psychiatry and Behavioral Sciences Department

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• Zhang X, Hack LM, Bertrand C, Hilton R, Gray NJ, Boyar L, Laudie J, Heifets BD, Suppes T, van Roessel PJ, Rodriguez CI, Deisseroth K, Knutson B, Williams LM. Negative Affect Circuit Subtypes and Neural, Behavioral, and Affective Responses to MDMA: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257803. doi: 10.1001/jamanetworkopen.2025.7803.

  PMID: 40305021 RESULT

Related Links

• Zhang et al JAMA Network Open

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Leanne M Williams, PhD

  Stanford PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 16, 2019
• Study Start: November 2, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)