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Psychedelic

Fasted Treatments with 100 mg of MDMA for Pharmacokinetics (MPKF Trial)

Phase 1
Waitlist Available
Led By William B Smith, M.D.
Research Sponsored by MAPS Public Benefit Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 1 day after drug administration
Awards & highlights

MPKF Trial Summary

This trial will give MDMA to people after either a fasting or high calorie meal to study how food affects the body's ability to process the drug. They will also monitor heart rate and any changes on an electrocardiogram.

MPKF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 1 day after drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 1 day after drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve from dosing time to last measurement - Plasma concentration of MDMA
Area under the curve from dosing time to last measurement - Plasma concentration of active metabolite MDA

MPKF Trial Design

2Treatment groups
Active Control
Group I: Fasted Treatments with 100 mg of MDMAActive Control1 Intervention
Following an overnight fast of at least 10 hours, participants will be administered 100 mg MDMA (equivalent to 120 mg MDMA HCl) with 240 mL of water. No food should be allowed for at least 4 hours post-dose.
Group II: Fed Treatments with 100 mg of MDMAActive Control1 Intervention
A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal will be used as a test meal for food-effect evaluation. Following an overnight fast of at least 10 hours, participants will start the recommended meal 30 minutes prior to administration of the drug product. Participants will eat this entire meal in 30 minutes or less. 100 mg MDMA (equivalent to 120 mg MDMA HCl) will be administered 30 minutes after start of the meal with 240 mL of water.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

MAPS Public Benefit CorporationLead Sponsor
29 Previous Clinical Trials
1,288 Total Patients Enrolled
1 Trials studying Pharmacokinetics
16 Patients Enrolled for Pharmacokinetics
Lykos TherapeuticsLead Sponsor
41 Previous Clinical Trials
1,625 Total Patients Enrolled
1 Trials studying Pharmacokinetics
16 Patients Enrolled for Pharmacokinetics
Multidisciplinary Association for Psychedelic StudiesLead Sponsor
39 Previous Clinical Trials
1,599 Total Patients Enrolled
1 Trials studying Pharmacokinetics
16 Patients Enrolled for Pharmacokinetics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Food Effects on Bioavailability of MDMA in Healthy Volunteers
2022. "Food Effects on Bioavailability of MDMA in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05147402.
~5 spots leftby Apr 2025
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