MDMA for Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how people with liver issues process MDMA, a substance sometimes used in therapy, compared to those with healthy livers. The goal is to determine if individuals with abnormal liver function absorb more MDMA and if their dosage needs adjustment. Participants will receive a single dose of MDMA and remain on-site for two days for various health checks. The trial seeks individuals with either moderate liver problems or normal liver function, and candidates must be willing to stay at the study site for the required duration. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
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 there any evidence suggesting that MDMA is likely to be safe for humans?
Studies have shown some risks of MDMA for the liver, linking it to liver damage and even liver failure. This poses a concern, especially for individuals with existing liver problems. Cases of MDMA-induced liver injury, though rare, highlight the importance of monitoring liver health when using MDMA.
Additionally, individuals with liver issues might process MDMA differently. This trial examines how much MDMA people with liver problems absorb and whether dose adjustments are necessary. Participants will receive one dose and undergo monitoring for any side effects. This approach ensures the treatment's safety and checks its tolerability.12345Why are researchers excited about this trial?
Unlike the standard treatments for liver disease, which typically involve lifestyle changes, medications like ursodeoxycholic acid, or even liver transplants, MDMA (specifically midomafetamine HCl) is being explored for its unique psychoactive properties. Researchers are excited about MDMA because it acts on serotonin receptors, potentially offering a novel mechanism to alleviate symptoms associated with liver disease. This approach is particularly intriguing as it may provide benefits beyond traditional treatments, possibly improving quality of life for patients with moderate hepatic impairment.
What evidence suggests that MDMA might be an effective treatment for liver disease?
Research on MDMA (also known as ecstasy) has shown that it can sometimes harm the liver and, in rare cases, cause liver failure. This suggests the drug might affect liver function, especially in individuals with existing liver problems. In this trial, one group of participants with moderate hepatic impairment will receive a single dose of 80 mg midomafetamine HCl. Another group, consisting of participants with normal hepatic function, will receive the same dose. The study aims to understand how MDMA is processed in people with liver issues compared to those with healthy livers. The goal is to determine if individuals with liver problems absorb more of the drug and if their dosage needs adjustment.12367
Who Is on the Research Team?
Janel Long-Boyle, PharmD, PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- MDMA
Trial Overview
The study tests how a single dose of MDMA affects individuals with moderate hepatic impairment compared to those with normal liver function. It measures the drug's peak levels in blood, time to reach peak levels, and overall exposure over time through frequent blood samples and mood assessments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Eight participants, each matched on age, weight and gender to a participant with moderate hepatic impairment, receive a single dose of 80 mg midomafetamine HCl.
Eight participants with moderate hepatic impairment receive a single dose of 80 mg midomafetamine HCl.
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
Citations
Hepatic injury and hepatic failure adverse events in 3,4- ...
There have been published case reports of liver injury and liver failure with detectable MDMA levels, suggesting a possible association of its use with DILI.
Hepatic injury and hepatic failure adverse events in 3,4- ...
There have been published case reports of liver injury and liver failure with detectable MDMA levels, suggesting a possible association of its use with DILI.
A Case of Ecstasy-Induced Acute Hepatic Injury - PMC
Although liver failure with ecstasy is rare, the use of the drug should be investigated in all patients with severe hepatitis of unknown origin.
MDMA in Subjects With Moderate Hepatic Impairment and ...
This protocol is for a Phase 1, open-label study with a primary purpose of evaluating the effect of moderate hepatic impairment in the pharmacokinetics of MDMA ...
Hepatic injury and hepatic failure adverse events in 3,4- ...
Hepatic injury and hepatic failure adverse events in 3,4-methylenedioxymethamphetamine users reported to the FDA Adverse Event Reporting ...
Severe chronic hepatitis secondary to prolonged use of ...
Use of ecstasy and cocaine may cause chronic hepatitis leading to marked liver fibrosis, which may regress after withdrawal of both substances.
Hepatic injury and hepatic failure adverse events in 3,4- ...
Majority of the drugs withdrawn from the market for liver injury caused death or transplantation at frequencies under 0.01%. Unfortunately, ...
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