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.

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

NCT IDNCT04060108

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-01

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.