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

16 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

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

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

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Ecstasy ingestion and fulminant hepatic failure: liver transplantation to be considered as a last therapeutic option. [2019]

2. Belgium pubmed.ncbi.nlm.nih.gov

Ecstasy induced acute hepatic failure. Case reports. [2017]

3. Spain pubmed.ncbi.nlm.nih.gov

[Variability of the clinical expression of Ecstasy-induced hepatotoxicity]. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mechanisms underlying the hepatotoxic effects of ecstasy. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Toxicity and deaths from 3,4-methylenedioxymethamphetamine ("ecstasy") [2019]

6. England pubmed.ncbi.nlm.nih.gov

Inhibition of MD2-dependent inflammation attenuates the progression of non-alcoholic fatty liver disease. [2019]

7. England pubmed.ncbi.nlm.nih.gov

MSDC-0602K, a metabolic modulator directed at the core pathology of non-alcoholic steatohepatitis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Randomised clinical study: GR-MD-02, a galectin-3 inhibitor, vs. placebo in patients having non-alcoholic steatohepatitis with advanced fibrosis. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Galectin-3 and IL-33/ST2 axis roles and interplay in diet-induced steatohepatitis. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Effect of Mastiha supplementation on NAFLD: The MAST4HEALTH Randomised, Controlled Trial. [2021]