Enrollment in our food effect study on the bioavailability of MDMA in healthy volunteers is expected to begin in April 2022. This study will be conducted at a Phase 1 clinical research unit in Knoxville, Tennessee, and will enroll 12 healthy volunteers.
Participants will have two dosing sessions at least two weeks apart and will check into the clinical research unit the night before the dosing session. In one dosing session, participants will consume a high-calorie meal prior to dosing, and in the other session, dosing will happen while the participant is in a fasted state. Participants will remain in the unit for two days after dosing during which time blood will be drawn at specified time points to assess the effect that food has on the bioavailability of MDMA. There is no therapy component to this study.
