16 Participants Needed

MDMA for Liver Disease

RO
Overseen ByRecruitment Officer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

MDMA, also known as ecstasy, has been linked to serious liver damage, including cases of severe hepatitis and liver failure, which can be fatal. Some people have needed liver transplants after using MDMA, so it is important to be aware of these potential risks.12345

How does the drug MDMA differ from other treatments for liver disease?

MDMA is unique in liver disease treatment as it is primarily known for its use in mental health conditions like PTSD, and its application in liver disease is novel, potentially targeting inflammation differently than existing treatments.678910

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

JL

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

Negative urine test for drugs of abuse at Screening and prior to trial drug administration
Able to comprehend and willing to sign an informed consent form
My liver functions are normal with no significant health issues.
See 3 more

Exclusion Criteria

My liver function is stable and not worsening rapidly.
Have a PR interval > 240 ms, QRS > 110 ms or a history of prolongation of QT interval
Have a known or suspected allergy to trial product or related products
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive a single dose of 80 mg MDMA and undergo pharmacokinetic and safety assessments

3 days
Continuous monitoring at study site

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood draws and ECGs

15 days
Multiple visits for blood draws and ECGs

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Normal hepatic functionExperimental Treatment1 Intervention
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.
Group II: Moderate hepatic impairmentExperimental Treatment1 Intervention
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:

🇺🇸
Approved in United States as MDMA for:
  • Posttraumatic stress disorder (PTSD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

MAPS Public Benefit Corporation

Lead Sponsor

Trials
30
Recruited
900+

Lykos Therapeutics

Lead Sponsor

Trials
32
Recruited
960+

Multidisciplinary Association for Psychedelic Studies

Lead Sponsor

Trials
40
Recruited
1,200+

References

Ecstasy ingestion and fulminant hepatic failure: liver transplantation to be considered as a last therapeutic option. [2019]
Ecstasy induced acute hepatic failure. Case reports. [2017]
[Variability of the clinical expression of Ecstasy-induced hepatotoxicity]. [2019]
Mechanisms underlying the hepatotoxic effects of ecstasy. [2019]
Toxicity and deaths from 3,4-methylenedioxymethamphetamine ("ecstasy") [2019]
Inhibition of MD2-dependent inflammation attenuates the progression of non-alcoholic fatty liver disease. [2019]
MSDC-0602K, a metabolic modulator directed at the core pathology of non-alcoholic steatohepatitis. [2018]
Randomised clinical study: GR-MD-02, a galectin-3 inhibitor, vs. placebo in patients having non-alcoholic steatohepatitis with advanced fibrosis. [2021]
Galectin-3 and IL-33/ST2 axis roles and interplay in diet-induced steatohepatitis. [2021]
Effect of Mastiha supplementation on NAFLD: The MAST4HEALTH Randomised, Controlled Trial. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security