Phase 2 PTSD Trial, Recruiting

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

Who might be able to join this trial:

For the person with PTSD:

• People who have a diagnosis of PTSD that meets the study's criteria.
• People who have a close person in their life (such as a partner, family member, or friend) who is willing and able to take part in the study alongside them.
• People who are at least 18 years old.
• People who live in Ontario within the Greater Toronto Area (GTA).
• People who are in good general physical health.
• People who can speak and read English well.
• People who are willing to have all their visits recorded on audio and video.
• People who are able to swallow pills.
• People who are willing to follow all study rules and attend all required medical and therapy appointments.
• People who are currently in therapy and are willing to allow study therapists to speak directly with their existing therapist.
• People who are willing to stop taking psychiatric medications, herbal supplements, and all other prescription and non-prescription medications for the duration of the study.
• People who agree to stay overnight on two separate occasions following each full-day MDMA-assisted therapy session, and who agree not to drive for at least 24 hours after taking MDMA.
• People who are not pregnant and who agree not to become pregnant during the study (if pregnancy is possible for them).
• People who have a supportive relative, spouse, close friend, or caregiver — who is not taking part in the study — available to act as an emergency contact.
• People who agree to inform the research team within 48 hours of any new medical conditions or procedures.
• People who agree not to join any other clinical trials during the study period.

For the close significant other (the supporting person joining alongside the PTSD participant):

• People who have a close relationship with someone in the study who has PTSD and who is willing and able to participate.
• People who are at least 18 years old.
• People who live in Ontario within the Greater Toronto Area (GTA).
• People who are in good general physical health.
• People who can speak and read English well.
• People who are willing to have all their visits recorded on audio and video.
• People who are able to swallow pills.
• People who are willing to follow all study rules and attend all required medical and therapy appointments.
• People who are currently in therapy and are willing to allow study therapists to speak directly with their existing therapist.
• People who are willing to stop taking psychiatric medications, herbal supplements, and all other prescription and non-prescription medications for the duration of the study.
• People who agree to stay overnight on two separate occasions following each full-day MDMA-assisted therapy session, and who agree not to drive for at least 24 hours after taking MDMA.
• People who are not pregnant and who agree not to become pregnant during the study (if pregnancy is possible for them).
• People who have a supportive relative, spouse, close friend, or caregiver — who is not taking part in the study — available to act as an emergency contact.
• People who agree to inform the research team within 48 hours of any new medical conditions or procedures.
• People who agree not to join any other clinical trials during the study period.

Who may not be able to join:

For the person with PTSD:

• People who are pregnant, or who could become pregnant and are not using birth control.
• People who have a history of, or currently have, a psychotic disorder, bipolar 1 disorder, or dissociative identity disorder.
• People who have a history of a medical condition that could make receiving MDMA unsafe, such as glaucoma, heart attack, stroke, or aneurysm.
• People who have a history of Type 2 diabetes that a doctor considers to be unstable.
• People who have an underactive thyroid (hypothyroidism) and are not currently taking thyroid replacement medication.
• People who have high blood pressure, a history of heart disease, heart failure, an irregular heartbeat, or who require heart medication.
• People who have symptomatic liver disease.
• People who have a history of low sodium levels in the blood (hyponatremia), which can cause confusion, seizures, fatigue, or reduced consciousness.
• People who have a history of dangerous overheating of the body (hyperthermia).
• People who weigh less than 48 kg.
• People who have recently engaged in suicidal behaviour or experienced serious suicidal thoughts (this will be assessed by the study team).
• People who currently require ongoing treatment with psychiatric medication.
• People who currently have an eating disorder involving purging behaviours.
• People who currently have severe depression with psychotic features.
• People who pose a serious risk of harm to others.
• People who have recently received Electroconvulsive Therapy (ECT), a treatment that uses electrical stimulation to the brain.
• People who have recently taken part in ketamine-assisted therapy or used ketamine.
• People who currently have a substance use disorder with physical dependence (not including caffeine or nicotine).
• People who have recently used "Ecstasy" (substances sold as containing MDMA).
• People who are not able to give informed consent to participate.
• People who are not able to meet the attendance, scheduling, and procedural requirements of the trial.
• People who are currently involved in compensation-related legal proceedings where financial benefit could result from ongoing PTSD or other psychiatric symptoms.

For the close significant other:

• People who themselves meet the diagnostic criteria for PTSD.
• People who are pregnant, or who could become pregnant and are not using birth control.
• People who have a history of, or currently have, a psychotic disorder, bipolar 1 disorder, or dissociative identity disorder.
• People who have a history of a medical condition that could make receiving MDMA unsafe, such as glaucoma, heart attack, stroke, or aneurysm.
• People who have a history of Type 2 diabetes that a doctor considers to be unstable.
• People who have an underactive thyroid (hypothyroidism) and are not currently taking thyroid replacement medication.
• People who have high blood pressure, a history of heart disease, heart failure, an irregular heartbeat, or who require heart medication.
• People who have symptomatic liver disease.
• People who have a history of low sodium levels in the blood (hyponatremia), which can cause confusion, seizures, fatigue, or reduced consciousness.
• People who have a history of dangerous overheating of the body (hyperthermia).
• People who weigh less than 48 kg.
• People who have recently engaged in suicidal behaviour or experienced serious suicidal thoughts (this will be assessed by the study team).
• People who currently require ongoing treatment with psychiatric medication.
• People who currently have an eating disorder involving purging behaviours.
• People who currently have severe depression with psychotic features.
• People who pose a serious risk of harm to others.
• People who have recently received Electroconvulsive Therapy (ECT).
• People who have recently taken part in ketamine-assisted therapy or used ketamine.
• People who currently have a substance use disorder with physical dependence (not including caffeine or nicotine).
• People who have recently used "Ecstasy" (substances sold as containing MDMA).
• People who are not able to give informed consent to participate.
• People who are not able to meet the attendance, scheduling, and procedural requirements of the trial.
• People who are currently involved in compensation-related legal proceedings where financial benefit could result from ongoing PTSD or other psychiatric symptoms.

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