What side effects are associated with this type of intervention?

Common treatments for liver disease, such as antiviral therapies for hepatitis C, often include medications like simeprevir and sofosbuvir. These treatments are generally well tolerated but can cause side effects such as fatigue, headache, nausea, anemia, and hyperbilirubinemia. In some cases, photosensitivity and rash have also been reported. For patients with cholestasis, treatments like ursodeoxycholic acid (UDCA) are used, which can improve liver enzyme levels and reduce itching but may cause gastrointestinal disturbances. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate any adverse effects effectively.

What prior FDA approvals exist?

FDA-approved treatments for liver diseases include ursodeoxycholic acid (UDCA) for primary biliary cirrhosis, which has shown efficacy in delaying disease progression and improving survival rates. Obeticholic acid is another approved treatment for patients with an inadequate response to UDCA. Additionally, antiviral therapies such as simeprevir plus sofosbuvir have been approved for the treatment of chronic hepatitis C, demonstrating significant sustained virologic response rates. These treatments focus on managing liver disease progression and improving patient outcomes, similar to the pharmacokinetic evaluations being studied for MDMA in individuals with moderate hepatic impairment.

What other types of research exist?

Promising alternatives to MDMA for liver disease patients include medications with minimal hepatic metabolism or those known to be safe in hepatic impairment. These could include certain benzodiazepines like lorazepam, which is less dependent on liver function for metabolism, or newer agents being studied for their safety profile in hepatic impairment. Consulting with a healthcare provider for personalized recommendations is essential.

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MDMA for Liver Disease

Phase 1

Waitlist Available

Led By Janel Long-Boyle, PharmD, PhD

Research Sponsored by MAPS Public Benefit Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with normal hepatic function: no clinically significant findings from medical history, physical examination, laboratory values within protocol defined parameters

Participants with moderate hepatic impairment (class B according to Child-Pugh's criteria)

Must not have

Have mental incapacity, unwillingness or language barriers precluding adequate understanding or subject cooperation

Are unwilling to stay in the clinical unit for the required duration as per the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up -4 days to 15 days post drug administration

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include changes in mood and sensory perception shortly after taking MDMA. Physiological effects may include altered heart rate, blood pressure changes, increased body temperature during the initial days following administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver functions are normal with no significant health issues.

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My liver function is moderately impaired.

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I am between 18 and 65 years old.

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My weight is over 45 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand and can follow the study's requirements.

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I am willing to stay in the clinical unit as required.

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I have a specific liver condition or have had a liver transplant or shunt.

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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ -4 days to 15 days post drug administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~-4 days to 15 days post drug administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and -4 days to 15 days post drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under curve from dosing time to last measurement (AUC(0-t) MDA

Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA

Secondary study objectives

90% CL between hepatic impaired and no hepatic impairment groups for AUC (0-infinity)

90% CL between hepatic impaired and no hepatic impairment groups for AUC (0-t)

90% CL between hepatic impaired and no hepatic impairment groups for Cmax

+28 more

Side effects data

From 2010 Phase 2 trial • 23 Patients • NCT00090064

33%

Muscle tightness

20%

Diarrhea

13%

Irritability

13%

Anxiety

13%

Feeling hot

13%

Musculoskeletal pain

13%

Upper respiratory tract infection

13%

Visual impairment

Muscle strain

Laryngitis

Urinary tract infection

Burning sensation

Anorexia

Panic attack

Bruxism

Muscle spasms

Major depression

Syncope

Chills

Asthenia

Influenza like illness

Back pain

Clavicle fracture

Myoclonus

Depressed mood

Derealisation

Dissociation

Disturbance in attention

Dizziness

Dyspepsia

Dysuria

Foot operation

Headache

Nausea

Neck pain

Nocturia

Oropharyngeal blistering

Oropharyngeal pain

Pharyngitis streptococcal

Sinus headache

Tension headache

Vomiting

Ovarian cyst

Pain

Sinus tachycardia

Sinusitis

Vision blurred

Hypoaesthesia facial

100%

80%

60%

40%

20%

Study treatment Arm

SRRs: Placebo With Therapy

MDMA-assisted Therapy

Placebo With Therapy

SRRs: MDMA-assisted Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midomafetamine HCl

2004

Completed Phase 2

~30

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver disease, such as ursodeoxycholic acid (UDCA) and direct-acting antivirals (DAAs) for hepatitis C, work by different mechanisms. UDCA improves bile flow and reduces liver inflammation, while DAAs target specific steps in the viral replication cycle to eliminate the hepatitis C virus. Understanding these mechanisms is crucial for liver disease patients because impaired liver function can alter drug metabolism and efficacy, necessitating dosage adjustments to avoid toxicity and ensure therapeutic effectiveness. This is particularly relevant in studies like the MDMA pharmacokinetic evaluation, which assess how liver impairment affects drug processing and safety.

5-Fluorouracil, mitomycin, and doxorubicin (FAM) in carcinoma of the biliary tract.Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.