Stanford Regulating Circuits of the Brain Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-02

Study Completion Date

2024-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stanford Regulating Circuits of the Brain Study- Ketamine

NCT03475277

Healthy

COMPLETED

Evaluation of MDMA on Startle Response

NCT03181763

Startle Response

COMPLETED PHASE1

Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)

NCT04073433

Psychological Effects of Study Drug

WITHDRAWN PHASE1

Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers

NCT01404754

Psychological Effects of Study Drug

COMPLETED PHASE1

Functional Brain Imaging in Recreational Users of Ecstasy

NCT00254306

Amphetamine-Related Disorders

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will assess the effect of acute MDMA modulation on the functioning of human brain circuits. Brain circuits will be assessed using functional magnetic resonance imaging.

Participants will include volunteers who report more than two prior uses of MDMA (also known as Ecstasy), when they were 18 years or older.

The investigators will recruit individuals who have previously tried MDMA rather than those who are MDMA-naïve.

Participants will receive an oral dose of MDMA (80mg and 120mg) and placebo (saline) at 3 separate study sessions. Following established procedures, these three sessions will be randomized in a blinded protocol in order to limit expectancy effects.

Throughout each session, participants will be monitored. Functional imaging will commence after the drug has reached peak levels, following previously established time courses for MDMA administered orally. Participants will also be monitored after the functional imaging session. Secondary effects of MDMA on behavior and self-reported experience will be assessed.

In the assessment of the acute effects of MDMA, the investigators will take into account the cumulative effects of prior drug exposure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MDMA Within Subject Cross-over

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

MDMA

Intervention Type DRUG

80mg, 120mg, Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MDMA

80mg, 120mg, Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

3,4-Methyl enedioxy methamphetamine, ecstasy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

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.
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 Investigator.
11. BMI outside of healthy range (18-30)
12. Inability to speak, read or understand English at a 5th grade level or severe hearing impairment.
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 appointment)
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 bradycardia)
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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes