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 served as veterans of special forces undercover units in the Israeli army.
• People who are fluent in speaking and reading Hebrew.
• People who are able to swallow pills.
• People who agree to have their study visits recorded, including therapy sessions and experimental sessions.
• People who can provide a contact person (such as a relative, spouse, or close friend) who is willing to be reached by the research team if needed.
• People who agree to inform the research team within 48 hours of any new medical conditions or procedures.
• People who agree to follow certain lifestyle rules during the study, such as fasting before certain sessions, not joining other clinical trials, staying overnight at the study site after experimental sessions, and following all study procedures.
• People who, at the screening stage, are diagnosed with PTSD (a condition caused by traumatic experiences) that has lasted 6 months or longer, based on standard medical guidelines.
• People who, at the screening stage, have at least moderate PTSD symptoms in the past month, based on a standard symptom checklist score of 36 or higher.
• People who have high blood pressure that is well managed with treatment.
• People who have Hepatitis C (a liver infection) but have no symptoms from it.
• People who have a history of, or currently have, alcohol or substance use disorder.
• People who have a history of, or currently have, Type 2 diabetes.
• People who have an underactive thyroid and are taking stable, adequate thyroid medication for it.
• People who have a history of, or currently have, glaucoma (an eye condition), provided an eye specialist has approved their participation.

Who may not be able to join:

• People who are not able to give informed consent to participate in the study.
• People who have used ecstasy (a substance said to contain MDMA) more than 10 times in the last 10 years, or at least once in the 6 months before the first experimental session, or who have previously taken part in an MDMA clinical trial run by MAPS.
• People who have any current issue that, in the opinion of the study doctor or investigator, could interfere with taking part in the study.
• People who have a known sensitivity or allergy to any of the study substances or their ingredients that the study team considers a reason not to participate.
• People who have received electroconvulsive therapy (a medical treatment involving brief electrical stimulation of the brain) within 12 weeks before joining the study.
• People who have a history of, or currently have, a primary psychotic disorder (a condition involving a break from reality, such as schizophrenia).
• People who currently have an eating disorder that involves purging behaviours, as assessed through clinical interview.
• People who currently have severe depression with psychotic features, as assessed through clinical interview.
• People who currently have an alcohol or substance use disorder (other than caffeine or nicotine) that the study team considers a safety concern.
• People who have had an active illicit drug (other than cannabis) or prescription drug use disorder of any severity within the 12 months before joining the study.
• People who currently have a diagnosed personality disorder.
• People who are currently assessed as having a serious risk of suicide.
• People who need to continue taking psychiatric medications during the study, except where the study protocol specifically allows for exceptions.
• People who have a medical history that could make it unsafe to receive a drug that raises blood pressure and heart rate.
• People who have uncontrolled high blood pressure, defined as a reading of 140/90 mmHg or higher measured on three separate occasions.
• People who have a history of a serious irregular heart rhythm (ventricular arrhythmia), other than a specific minor and harmless type, in the absence of heart disease.
• People who have a specific heart condition called Wolff-Parkinson-White syndrome or a similar condition that has not been successfully treated.
• People who have had a significant irregular heart rhythm within the 12 months before screening, other than minor and harmless types in the absence of heart disease.
• People who have a significantly prolonged electrical reading on a heart tracing (QTc interval above 450ms for males and above 460ms for females).
• People who have additional risk factors for a specific serious heart rhythm problem called Torsade de pointes (for example, heart failure, low potassium levels, or a family history of Long QT Syndrome).
• People who need to take other medications during experimental sessions that are known to affect heart rhythm in a particular way (QT interval prolongation).
• People who have active liver disease with symptoms, or significantly elevated liver enzyme levels.
• People who have a history of dangerously low sodium levels or dangerously high body temperature.
• People who weigh less than 48 kilograms.
• People who have used ketamine (a medical and recreational substance) or participated in ketamine-assisted therapy within 12 weeks before joining the study.

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