MedTrace Logo

Food Effects on Bioavailability of MDMA in Healthy Volunteers

NCT05147402 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-10-30

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if food impacts absorption of MDMA in participants who are either fed or fasted.

The main question it aims to answer is: What is the effect of eating food on the safety of taking oral MDMA?

Researchers will compare participants who are fasted for 10 hours to participants who are fed a high-fat and high-calorie meal.

Participants will be randomized to either the fed or fasted group, then be administered MDMA. Vitals and blood samples will be taken. Then, participants will be assigned to the opposite condition and vitals and blood samples will be taken.

Conditions

  • Pharmacokinetics

Interventions

DRUG

midomafetamine

100 mg midomafetamine (equivalent to 120 mg midomafetamine HCl).

Sponsors & Collaborators

Principal Investigators

  • William B Smith, M.D. · Alliance for Multispecialty Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-28
Primary Completion
2022-12-02
Completion
2022-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05147402 on ClinicalTrials.gov