Phase 3 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 were assigned male sex at birth and currently identify as male (not transgender and not taking hormone therapy)
• People who have served in the Israeli military
• People who are at least 18 years old
• People who can speak and read Hebrew fluently
• People who are able to swallow pills
• People who agree to have brain activity (EEG) recordings taken three times during the study, and saliva samples collected during experimental sessions
• People who agree to have study visits recorded, including therapy sessions and assessments by independent raters
• People who can provide a contact person (such as a relative, spouse, or close friend) who can be reached by the research team if the participant becomes unwell or cannot be contacted
• People who agree to inform the research team within 48 hours of any new medical conditions or procedures
• People who agree to fast before experimental sessions, avoid certain medications before sessions, stay overnight at the study site after each experimental session, be driven home afterwards, and not join any other clinical trials during the study
• People who, at the screening stage, have been diagnosed with PTSD related to military service (according to standard diagnostic guidelines, called DSM-5), with symptoms lasting at least 6 months, and who have previously tried at least one psychiatric or psychological treatment
• People whose PTSD symptoms score at least 33 on a standard questionnaire (PCL-5) and at least 28 on a clinician-administered assessment (CAPS-5) at screening
• People who weigh at least 45 kilograms (people weighing between 45–48 kg must also have a body mass index between 18 and 30)
• People who are able to give their own informed consent to participate

Who may not be able to join:

• People with certain abnormal liver blood test results (elevated ALT, AST, or bilirubin levels above specified limits)
• People with unstable liver or bile duct disease, such as cirrhosis, persistent jaundice, or related complications (some stable liver conditions may be acceptable — confirm with trial site)
• People with a recent history of clinically significant low sodium levels in the blood or dangerous overheating
• People with a heart electrical measurement (QTcF interval) above 450 milliseconds on repeated heart tracings (ECG), unless a medication is suspected to be causing this (confirm with trial site)
• People with a history of medical conditions that could make it harmful to receive a drug that raises blood pressure and heart rate — such as a previous heart attack, stroke, heart failure, severe coronary artery disease, or aneurysm
• People with uncontrolled high blood pressure (repeatedly measuring 140/90 mmHg or higher), unless it is well managed with medication and a risk assessment is passed (confirm with trial site)
• People with a history of serious abnormal heart rhythms (ventricular arrhythmia), other than occasional minor irregular beats with no underlying heart disease
• People with Wolff-Parkinson-White syndrome or similar heart rhythm conditions that have not been successfully treated
• People with a history of certain irregular heart rhythms within the 12 months before screening (some exceptions may apply if successfully treated — confirm with trial site)
• People with additional risk factors for a serious heart rhythm problem called Torsade de pointes (such as heart failure, low potassium, or a family history of Long QT Syndrome)
• People who have started a new form of mental health treatment within 12 weeks before enrolling, including electroconvulsive therapy (ECT) or ketamine-assisted therapy
• People who, in the investigator's opinion, are likely to be re-exposed to the traumatic event or another serious trauma during the study
• People with a current moderate or severe alcohol or cannabis use disorder within the 12 months before enrolling (mild or early-remission cases may be acceptable — confirm with trial site)
• People with a current substance use disorder involving illicit drugs (other than cannabis) or misuse of prescription drugs at any level of severity within the past 12 months
• People currently assessed as having a serious risk of suicide, including those with frequent serious suicidal thoughts in the past month, very high-severity suicidal thoughts in the past 6 months, or any suicidal behaviour (including attempts) in the past 6 months (a past history of attempts alone is not automatically an exclusion — confirm with trial site)
• People who are unable or unwilling to safely reduce or stop certain psychiatric medications as required by the study
• People who need to take medications that can affect heart rhythm during experimental sessions
• People who have used street ecstasy (MDMA) more than 10 times in the past 10 years, or at least once within 6 months of the first experimental session
• People currently enrolled in another clinical research study involving an experimental treatment (unless approved by the study clinician)
• People with a current personality disorder (assessed by a psychiatrist)
• People with a current eating disorder involving compensatory behaviours (such as purging)
• People with current major depression that includes psychotic features
• People with a history of, or currently having, a primary psychotic disorder, bipolar disorder type 1, or dissociative identity disorder
• People with a known allergy or sensitivity to any of the study treatments or their ingredients
• People currently involved in compensation claims where financial benefit could come from ongoing PTSD or psychiatric symptoms
• People who lack a support network or a stable place to live
• People who have previously taken part in a MAPS-sponsored MDMA clinical trial
• Employees (and their immediate family members) of MAPS or its related organisations, or people in a personal relationship with the site investigator
• People with any other current issue that, in the investigator's opinion, could interfere with their ability to participate safely
• People whose participation would coincide with a period of high risk of rocket attacks or air raid sirens (sessions will not be scheduled during such periods)
• People who have been actively involved in combat operations in the three months before starting the study
• People who have a partner or a first-degree family member (such as a parent, sibling, or child) currently serving in an active war zone during the study period
• People who do not have a permanent, safe place to live or who expect to move during the study

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