Trial Summary
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.
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.
+4 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
+14 more
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Alliance for Multispecialty Research, LLC.Knoxville, TN
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Who Is Running the Clinical Trial?
MAPS Public Benefit CorporationLead Sponsor
Lykos TherapeuticsLead Sponsor
Multidisciplinary Association for Psychedelic StudiesLead Sponsor