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:

• Veterans aged 18 to 64 who have been assessed and meet the criteria for PTSD with a severity score of 25 or higher on a standard clinical assessment tool called the CAPS-5.
• People who speak and read English fluently.
• People who are willing to attend all medication sessions, therapy sessions, follow-up appointments, and phone check-ins, and to complete required questionnaires.
• People who are able to swallow pills.
• People who agree to have their study visits, including therapy, assessment, and MDMA sessions, recorded by audio and/or video, and who understand that some sessions will be reviewed by an independent assessor.
• People who have someone available to drive them home after the MDMA session.
• People who can provide the name of a trusted contact person (such as a family member, spouse, or close friend) who investigators can reach in an emergency, such as if the participant becomes unreachable or is at risk of harming themselves.
• People who agree to inform the investigators within 48 hours of any new medical conditions or procedures that arise during the study.
• People who are able to become pregnant must have a negative pregnancy test at the start of the study and before the MDMA session, and must agree to use an approved form of birth control from one month before to ten days after the MDMA session (confirm with trial site for full list of accepted methods).
• People who agree to follow specific lifestyle guidelines around fasting and stopping or reducing certain medications before and after the MDMA session, which may include gradually tapering off antidepressants (SSRIs), ADHD medications, or other listed medications.
• People who agree not to participate in other PTSD-focused therapy programs during the study.
• People who agree not to join any other interventional clinical trials for the duration of this study.
• People who scored 40 or higher on a PTSD symptom checklist (PCL-5) in the month before the initial screening.
• People with well-controlled high blood pressure that is managed with medication may be eligible, provided additional heart health screening is passed (confirm with trial site).
• People with asymptomatic Hepatitis C that has previously been assessed and treated as needed may be eligible.
• People with an alcohol or substance use problem may be eligible if they are not currently in withdrawal or needing medical detox, and if they and the medical team agree on a realistic plan to reduce use during the study (a urine drug screen will be required before joining and before the MDMA session).
• People with a history of or current Type 2 Diabetes may be eligible if the condition is stable, well-managed, and additional heart health screening is passed, with approval from the study doctor.
• People with an underactive thyroid (hypothyroidism) may be eligible if they are on a stable and adequate thyroid medication.
• People with a history of or current glaucoma may be eligible if an eye specialist (ophthalmologist) approves their participation in the study.

Who may not be able to join:

• People who are not able to provide written informed consent.
• People who are currently involved in a compensation or pension legal claim where receiving payment depends on continuing to have PTSD or other psychiatric symptoms.
• People who, in the investigator's opinion, are likely to be exposed again to the traumatic event or another major trauma during the study, or who lack a stable home or sufficient social support.
• People who have previously used ecstasy (a substance sold as containing MDMA) or who have taken part in another MDMA clinical trial.
• People who test positive for amphetamine or cocaine at screening.
• People who have any current health problem that the investigator and study doctor believe could affect their safety or their ability to take part in the study.
• People who have a known allergy or sensitivity to any ingredient in the study drug.
• People who have received electroconvulsive therapy (ECT, sometimes called "shock therapy") within 12 weeks before joining the study.
• People who have dementia.
• People who have a current or past primary psychotic disorder (a condition involving a significant break from reality, such as schizophrenia), as determined through clinical assessment.
• People who have a current or past diagnosis of Bipolar 1 disorder, Bipolar 2 disorder, or a manic episode, as determined through clinical assessment.
• People who currently have an eating disorder that involves purging behaviours.
• People who currently have severe depression with psychotic features.
• People who currently have panic disorder.
• People who have a history of amphetamine or cocaine use disorder.
• People who currently have an alcohol or substance use disorder (other than caffeine or nicotine) that the medical team considers a safety concern, or who are unwilling or unable to agree to and follow a plan to reduce use during the study. People with severe active alcohol or substance use symptoms above set score thresholds will be reviewed by the study doctors to decide if they can be included (confirm with trial site for score thresholds).
• People who are currently at serious risk of suicide, based on a clinical interview and a suicide assessment tool (C-SSRS score of 4 or higher), or who the investigator believes are likely to need hospitalisation for suicidal thoughts or behaviour. Specifically excluded are people who have had thoughts of suicide at a serious level (score of 4 or higher) happening once a week or more in the past 6 months, or who have made a suicide attempt or taken preparatory steps toward suicide in the past 6 months. A past history of suicide attempts alone does not automatically exclude someone.
• People who are considered a serious risk of harm to others.
• People who need to continue taking a psychiatric medication that is not permitted under the study's medication guidelines (confirm with trial site for the specific list).
• People who have a medical history that would make it harmful to receive a drug that raises blood pressure and heart rate — including, for example, a history of heart attack, stroke, or aneurysm. People with other mild, stable medical conditions may be considered on a case-by-case basis by the study doctors.
• People with uncontrolled high blood pressure, defined as repeated readings of 140 mmHg or higher (top number) or 90 mmHg or higher (bottom number).
• People with a history of serious irregular heartbeat (ventricular arrhythmia), except for occasional minor irregularities with no underlying heart disease.
• People with Wolff-Parkinson-White syndrome or a similar heart electrical pathway condition that has not been permanently corrected by a medical procedure.
• People with a history of certain types of irregular heartbeat within the past 12 months, unless the condition was successfully treated by a procedure and confirmed clear by a heart specialist for at least one year (confirm with trial site for full details).
• People who have a significantly prolonged heart electrical interval (QTcF greater than 450 milliseconds) on repeated measurements.
• People who 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.
• People who need to take medications during the study that are known to prolong the heart's electrical interval (confirm with trial site for the specific list).
• People with active liver disease or who have repeatedly had significantly elevated liver enzyme results on blood tests.
• People with a history of dangerously low sodium levels (hyponatremia) or dangerously high body temperature (hyperthermia).
• People with a BMI (body mass index) of 18.5 or below.
• People who are currently pregnant or breastfeeding, or people who are able to become pregnant and are not willing or able to use an effective method of birth control.
• People who have received ketamine-assisted therapy or have used ketamine within 12 weeks before joining the study.
• People with any pre-existing condition that affects how their kidneys function.

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