Phase 2 PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to provide proof of their veteran status.
• People who speak and read English fluently.
• People who, at the start of the study, meet the clinical criteria for Alcohol Use Disorder, as measured by a structured diagnostic interview called the SCID-5.
• People who are able to safely stop drinking alcohol for at least 48 hours without needing medical detox.
• People who, at the start of the study, have been diagnosed with PTSD (under current diagnostic guidelines) with symptoms lasting at least 6 months.
• People who, at the start of the study, score 33 or higher on a standard PTSD symptom checklist called the PCL-5.
• People who, at the start of the study, have a confirmed PTSD diagnosis based on a clinical interview called the CAPS-5, with a total severity score of 28 or higher.
• People who are able to swallow pills.
• People who agree to have their study visits recorded, including therapy sessions and assessments.
• People who can provide a contact person (such as a relative, spouse, close friend, or other support person) who is willing to be reached by the research team if the participant becomes unwell or unreachable.
• People who can identify a suitable support person to stay with them on the evenings following the experimental sessions.
• People who weigh at least 45 kilograms. People weighing between 45 and 48 kilograms must also have a body mass index (BMI) between 18 and 30.
• People assigned female sex at birth who are not pregnant, not planning to become pregnant, and not breastfeeding — and who either cannot become pregnant, or are using a highly effective form of contraception (with a failure rate of less than 1%). A negative pregnancy test at study entry and before each experimental session is also required.
• People who are able to give informed consent and agree to follow all study requirements.
• People who agree to inform the research team within 48 hours of any new medical conditions or procedures.
• People who have asymptomatic Hepatitis C that has previously been assessed and treated as needed.
• People who have a realistic, agreed-upon plan (approved by the investigator, therapy team, and study doctor) to reduce substance use and manage symptoms without self-medicating.
• People with a history of or current Type 2 Diabetes, if tests rule out underlying heart disease, the condition is stable and well managed, and the study doctor approves.
• People with an underactive thyroid (hypothyroidism), if they are on stable and adequate thyroid medication.
• People with a history of or current glaucoma, if an eye specialist (ophthalmologist) approves their participation.

Who may not be able to join:

• People with symptomatic liver disease or significantly elevated liver enzyme levels on blood tests.
• People with current unstable liver or bile duct disease, such as fluid in the abdomen, confusion related to liver disease, abnormal clotting, jaundice, or cirrhosis.
• People with a history of seizures or severe alcohol withdrawal (delirium tremens).
• People currently showing significant alcohol withdrawal symptoms, as measured by a clinical assessment tool.
• People with a recent history of clinically significant low sodium levels or dangerously high body temperature.
• People with a significantly prolonged heart rhythm measurement (QTcF interval above 450 ms) on repeated ECG tests (confirm with trial site for details on exceptions).
• People with a history of any medical condition that could make receiving a drug that raises blood pressure and heart rate unsafe — including heart attack, stroke, heart failure, severe coronary artery disease, or aneurysm.
• People with controlled or uncontrolled high blood pressure (readings of 140 mmHg systolic or higher, or 90 mmHg diastolic or higher, on repeated measurements).
• People with a history of serious abnormal heart rhythms (ventricular arrhythmia), other than occasional minor irregularities in the absence of heart disease.
• People with Wolff-Parkinson-White syndrome or any other extra electrical pathway in the heart that has not been successfully treated.
• People with a history of abnormal heart rhythms (other than minor irregularities) within the 12 months before screening, unless successfully treated as specified in the protocol.
• People with additional risk factors for a specific dangerous heart rhythm condition called Torsade de pointes (such as heart failure, low potassium, or a family history of Long QT Syndrome).
• People who cannot have an MRI due to non-removable metal implants, claustrophobia, or a history of head trauma.
• People who have started a new form of mental health treatment within 12 weeks before enrolment, including electroconvulsive therapy (ECT) or ketamine-assisted therapy.
• People currently prescribed antidepressant medications (such as SSRIs) that would require a gradual taper before starting the study (confirm with trial site, as tapering off SSRIs before study procedures may be possible).
• People currently prescribed antipsychotic medications.
• People who, in the investigator's opinion, are likely to be re-exposed to the trauma that caused their PTSD, or another serious trauma, during the study.
• People with a current moderate or severe cannabis use disorder (as defined by specific diagnostic criteria) within the 12 months before enrolment.
• People with an active disorder related to use of any other substance (other than cannabis or alcohol) within the 12 months before enrolment.
• People who have used Ecstasy (a substance sold as MDMA) more than 10 times in the past 10 years, or at least once within 6 months of the first experimental session.
• People who currently present a serious risk of suicide, as assessed through clinical interview, a standardised questionnaire, and the investigator's clinical judgement — including those with frequent or intense suicidal thoughts, or any suicidal behaviour, in the past 6 months.
• People who would present a serious risk of harm to others, as determined through clinical interview and contact with a treating psychiatrist.
• People who currently require ongoing psychiatric medication (with some exceptions outlined in the study protocol — confirm with trial site).
• People currently taking medications used to treat alcohol use, such as naltrexone or disulfiram.
• People who need to take medications during experimental sessions that could prolong the QT interval (a heart rhythm measurement).
• People currently receiving trauma-focused psychotherapy or enrolled in a treatment programme for substance use disorders (self-help programmes are not an exclusion).
• People currently enrolled in another clinical study involving an investigational treatment, unless approved by the study doctor.
• People with a history of or current primary psychotic disorder, Bipolar I disorder, or dissociative identity disorder.
• People with a current eating disorder that involves compensatory behaviours (such as purging).
• People with current major depressive disorder that includes psychotic features.
• People with certain current personality disorders, as assessed through a structured clinical interview.
• People who are not able to give informed consent.
• People with known sensitivity or allergy to any of the study medications or their components.
• People currently involved in legal compensation claims where financial benefit depends on continued PTSD or other psychiatric symptoms.
• People who do not have adequate social support or a stable living situation, or who cannot identify a support person to assist them after experimental sessions.
• People who have previously taken part in an MDMA clinical trial sponsored by MAPS.
• Employees (or their immediate family members) of MAPS, MAPS Public Benefit Corporation, or MAPS Europe B.V., or people in a personal relationship with the lead investigator.
• People with any other current issue that, in the opinion of the investigator or study doctor, might interfere with participation.

Important: Always verify eligibility with the trial site directly before applying.