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:

• You have been diagnosed with PTSD, confirmed through a structured clinical interview.
• You can speak and read English.
• You are willing to allow the study team to communicate with your regular doctor or mental health provider if needed.
• You are able to swallow pills.
• You agree to have your therapy sessions, assessments, and study visits recorded by video and/or audio.
• You can provide the name of a relative, spouse, close friend, or other support person who can be contacted by the study team.
• You agree to let the study team know within 48 hours if any new medical conditions or procedures come up during the study.
• If you can become pregnant, you must have a negative pregnancy test before and at the start of the study, and again before the medicine session; you must also use reliable birth control for one month before the medicine session and for 10 days after it.
• You agree to follow specific lifestyle rules, including fasting and avoiding certain medicines before the medicine session, not joining other interventional clinical trials at the same time, arranging a ride home or to a hotel after the medicine session, and following the study's medication, therapy, and procedure schedule.

Who may not be able to join:

• You are not able to give informed consent for yourself.
• You have previously taken part in an MDMA clinical trial sponsored by MAPS (Multidisciplinary Association for Psychedelic Studies).
• You have a current issue that the study doctor believes could interfere with your participation.
• You have a known allergy or sensitivity to any ingredient in the study medicine.
• You have a current or past medical or psychiatric diagnosis that the study team believes would make participation risky (confirm with trial site).
• You currently take psychiatric medications on an ongoing basis, unless you are able to safely taper off them under the guidance of your own doctor.
• You have a medical history that could make it dangerous to take MDMA, particularly conditions affected by increases in blood pressure or heart rate, or any other condition the study doctor believes poses a safety risk.
• You have an unstable medical condition that could interfere with participation.
• You have high blood pressure that is not controlled, confirmed on three separate occasions.
• You have a heart condition called Wolff-Parkinson-White syndrome or a similar heart rhythm problem that has not been fully treated.
• You have a history of dangerous or abnormal heart rhythms that the study doctor believes could pose a significant risk.
• You have an abnormal result on a heart tracing (ECG/electrocardiogram) test.
• You have additional risk factors for a specific type of dangerous heart rhythm called Torsade de Pointes — for example, heart failure, low potassium levels, or a family history of Long QT Syndrome.
• You take other medications that could interact with or affect the safety of the study medicine.
• You have active liver disease or significantly elevated liver enzyme levels.
• You have a history of dangerously low sodium levels or dangerous overheating (hyperthermia).
• You weigh less than 48 kilograms (approximately 105 lbs.).
• You are currently pregnant or breastfeeding.
• You have used ketamine or participated in ketamine-assisted therapy within 12 weeks before enrolling in the study.

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