MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This study is an open-label, single dose study evaluating the effect of moderate hepatic
impairment in the pharmacokinetics of MDMA and its active metabolite,
3,4-methylene-dioxyamphetamine (MDA) in order to decide whether an adjustment to the dosage
would be need for individuals with moderate hepatic function in comparison to individuals
with normal liver function. Eight participants with moderate hepatic impairment and eight
matched participants with normal hepatic function will take part in this study. All patients
will be evaluated to see if they meet criteria for study participation, with screening
including a physical examination including a 12-lead electrocardiogram (ECG) and questions
about mental and physical health. Participants who meet study criteria will stay at the study
site for three days. On Day 1, they will receive a single dose of 80 mg MDMA. For the next
seven to eight hours, participants will have blood collected and will rate their mood and
other experiences. They will stay at the study sight for two more days. Blood will be drawn
twice on the second day and once on the third day, and they will have their heart function
measured with ECG. Blood will be collected periodically during a 12-hour interval on the day
of drug administration. Blood will also be drawn 24, 36, 48, 72 and 96 hours after MDMA
administration. Participant mood and feelings or experiences on-drug (subjective effects)
will be measured a half-hour, one, two, four, six, and seven hours after receiving MDMA. ECG
will be performed every day at the same time upon enrollment (Day -4 or -3) and from the Day
1 (day of drug administration) to Day 5. Blood pressure, heart rate and body temperature on
Day 1 through 5. Blood samples will be used to compute the peak or maximum amount of MDMA and
MDA in blood (Cmax), the time until reaching peak MDMA or MDA (Tmax) and the area under curve
(AUC), or actual degree of exposure to drug. The primary outcome measure will be AUC for
MDMA. Finding out if there are differences in drug metabolism between people with normally
functioning livers and people whose livers do not function normally will help researchers
performing MDMA-assisted psychotherapy.
Phase:
Phase 1
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies