MDMA for Liver Disease

Overseen By Recruitment Officer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MAPS Public Benefit Corporation

Disqualifiers: Psychiatric diagnosis, Pregnancy, Hepatitis, Autoimmune liver disease, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 days

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

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.

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

Timeline for a Trial Participant

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

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?

Group I: Normal hepatic function Experimental Treatment 1 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 impairment Experimental Treatment 1 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)

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11217510/

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.

2. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1414622/full

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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9671195/

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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03606538

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 ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1414622/epub

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 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210740113001332

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.

7. researchgate.net researchgate.net/publication/381954385_Hepatic_injury_and_hepatic_failure_adverse_events_in_34-methylenedioxymethamphetamine_users_reported_to_the_FDA_Adverse_Event_Reporting_System

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, ...