MDMA for Liver Disease
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is MDMA safe for humans?
How does the drug MDMA differ from other treatments for liver disease?
What is the purpose of this trial?
This trial studies how people with liver problems process MDMA compared to those with healthy livers. MDMA increases brain chemicals to improve mood and communication, which can make therapy sessions more effective for PTSD. The study will help determine if dosage adjustments are needed for people with liver issues. MDMA, also known as Ecstasy, has been used effectively to treat PTSD.
Research Team
Janel Long-Boyle, PharmD, PhD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for adults aged 18-65 with moderate liver impairment (Child-Pugh class B) or normal liver function, weighing over 45 kg. They must not be pregnant/nursing, using effective birth control if applicable, and have no drug abuse history. Participants should not have severe allergies or significant medical conditions that could affect the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of 80 mg MDMA and undergo pharmacokinetic and safety assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood draws and ECGs
Treatment Details
Interventions
- MDMA
MDMA is already approved in United States for the following indications:
- Posttraumatic stress disorder (PTSD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
MAPS Public Benefit Corporation
Lead Sponsor
Lykos Therapeutics
Lead Sponsor
Multidisciplinary Association for Psychedelic Studies
Lead Sponsor