← Back to Search

Other

MDMA for Liver Disease

Phase 1

Waitlist Available

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up -4 days to 15 days post drug administration

Awards & highlights

Study Summary

This trial is testing whether an adjustment to the dosage of MDMA is needed for people with moderate hepatic impairment, by comparing the pharmacokinetics of the drug in these individuals to people with normal liver function.

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.Check my eligibility

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.See study design

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

Select...

My liver functions are normal with no significant health issues.

Select...

My liver function is moderately impaired.

Select...

I am between 18 and 65 years old.

Select...

My weight is over 45 kg.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 2020 Phase 3 trial • 100 Patients • NCT03537014

72%

Headache

61%

Muscle Tightness

52%

Decreased Appetite

46%

Suicidal Ideation

43%

Insomnia

33%

Anxiety

30%

Fatigue

30%

Nausea

26%

Viral Upper Respiratory Tract Infection

22%

Hyperhidrosis

20%

Feeling Cold

20%

Dizziness

15%

Nightmare

15%

Asthenia

15%

Mydriasis

15%

Restlnessness

13%

Dizziness Postural

13%

Nystagmus

13%

Tremor

13%

Bruxism

13%

Abdominal Discomfort

11%

Feeling Jittery

11%

Dry Mouth

11%

Back Pain

11%

Depressed Mood

11%

Upper Respiratory Tract Infection

11%

Blood Pressure Increased

11%

Paraesthesia

11%

Abdominal Pain Upper

Vomiting

Feeling Hot

Musculoskeletal Pain

Palpitations

Non-Cardiac Chest Pain

Vision Blurred

Depression

Disturbance in Attention

Stress

Intrusive Thoughts

Pain

Pollakiuria

Feeling of Body Temperature Change

Arthralgia

Temperature Intolerence

Muscle Spasms

Chills

Muscle Twitching

Flashback

Pain in Jaw

Anger

Micturition Urgency

Nervousness

Feeling Abnormal

Hypoaesthesia

Somnolence

Substance Use

Ear Pain

Myalgia

Vertigo

Influenza

Dysmenorrhoea

Pyrexia

Influenza Like Illness

Diarrhea

Emotional Disorder

Irritability

Neck Pain

Agitation

Oropharyngeal Pain

Emotional Distress

Dissociation

Panic Attack

Intentional Self-Injury

100%

80%

60%

40%

20%

Study treatment Arm

MDMA-assisted Therapy

Placebo With Therapy

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 MDMA.

Group II: Moderate hepatic impairmentExperimental Treatment1 Intervention

Eight participants with moderate hepatic impairment receive a single dose of 80 mg MDMA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midomafetamine

2014

Completed Phase 3

~310

0 / 4Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

MAPS Public Benefit CorporationLead Sponsor

29 Previous Clinical Trials

1,286 Total Patients Enrolled

Lykos TherapeuticsLead Sponsor

41 Previous Clinical Trials

1,623 Total Patients Enrolled

Multidisciplinary Association for Psychedelic StudiesLead Sponsor

39 Previous Clinical Trials

1,597 Total Patients Enrolled

Media Library

MDMA (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03606538 — Phase 1

Liver Disease Research Study Groups: Moderate hepatic impairment, Normal hepatic function

Liver Disease Clinical Trial 2023: MDMA Highlights & Side Effects. Trial Name: NCT03606538 — Phase 1

MDMA (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03606538 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree has MDMA been explored in clinical investigation?

"Presently, there are 9 ongoing clinical trials focusing on MDMA with 1 study concluding its phase 3. These studies can be found across 18 locations worldwide - the majority being in Knoxville, Tennessee."

Answered by AI

Are there still opportunities to join this trial as a participant?

"Unfortunately, no more participants can be accepted for this study. It was published on March 29th 2024 and the details last modified on August 17th 2022. On the other hand, there are 296 trials accepting individuals with hepatic impairment and 9 clinical studies searching for patients to test MDMA's efficacy."

Answered by AI

Has the FDA sanctioned MDMA for therapeutic use?

"The safety rating for MDMA is assessed at a 1 given the current Phase 1 status, implying there has yet to be sufficient research into its efficacy or safe usage."

Answered by AI

What is the key purpose of this exploration?

"This clinical trial will measure Area under curve from dosing time to last measurement (AUC(0-t) MDA over a five day period. Other metrics of interest include Change in QTcI - Baseline to 2 h post-drug, Pre-drug Systolic blood pressure (SBP), and Change in QTcI Baseline to 4 h post-drug."

Answered by AI

What is the current enrollment for this clinical trial?

"This medical trial is not presently looking for participants. Its initial posting was on March 29th, 2024 and its most recent update was August 17th 2022. If you are searching other studies related to hepatic impairment, there are currently 296 trials open while 9 clinical trails with MDMA as an intervention remain active."

Answered by AI

Is geriatric inclusion a factor in this scientific experiment?

"This study is open to any patient aged 18 and above, up until 65 years old."

Answered by AI

Am I eligible to participate in this experiment?

"This research aims to enrol 16 individuals aged between 18 and 65 who are suffering from hepatic impairment. The ideal candidate should weigh more than 45 kg, fall within the aforementioned age range, and have moderate liver dysfunction as classified by Child-Pugh's criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function

2024. "MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03606538.

All > Liver Disease