CompletedPhase 1MDMA

Food Effects on Bioavailability of MDMA in Healthy Volunteers

NCT ID

NCT05147402

Target Enrollment

14 participants

Start Date

2022-07-28

Est. Completion

2022-12-05

About This Study

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 Studied

Pharmacokinetics

Interventions

•midomafetamine

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:Yes

View full eligibility criteria

Inclusion Criteria:

* Are fluent in speaking and reading the predominantly used or recognized language of the study site.
* Are able to swallow pills.
* If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 7 days after the last Experimental Session.

Exclusion Criteria:

* Are not able to give adequate informed consent.
* Have uncontrolled hypertension.
* Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] corrected by Bazett's formula).
* Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
* Have evidence or history of significant medical disorders.
* Have symptomatic liver disease.
* Have history of hyponatremia or hyperthermia.
* Weigh less than 48 kilograms (kg).
* Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
* Are abusing illegal drugs.

Study Locations (1)

Alliance for Multispecialty Research LLC