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 were assigned female or male at birth.
• People aged between 21 and 65 years old at the time of screening.
• People with a body mass index (a measure of body weight relative to height) between 18 and 30 at the time of screening.
• People who have been formally diagnosed with PTSD, confirmed through a structured clinical interview using recognised diagnostic tools.
• People whose PTSD is rated as moderate to severe, and who also have at least moderate depression, based on specific clinical assessment scores.
• People capable of producing sperm must use a condom throughout the trial and for 3 months after taking the trial medication, and if their partner could become pregnant, that partner must also use a highly effective form of contraception during the same period — condoms alone or abstinence are not considered highly effective for this purpose.
• People who could become pregnant must use a highly effective form of contraception alongside a condom used by a sperm-producing partner, throughout the trial and for 3 months after dosing — condoms alone or abstinence are not considered highly effective for this purpose — and must have a negative pregnancy test at screening and at the first dosing visit.
• People who cannot become pregnant (such as those who are post-menopausal or have had certain surgical procedures such as removal of the uterus, fallopian tubes, or ovaries) must meet specific medical definitions of those conditions (confirm with trial site).
• People who are able to give written informed consent and agree to follow the requirements set out in the consent form.
• People who are fluent in English, as all study materials and assessments are conducted in English.

Who may not be able to join:

• People with heart disease, including coronary artery disease or congestive heart failure.
• People with a current or past diagnosis of schizophrenia or related psychotic disorders, bipolar disorder, or a current diagnosis of a personality disorder.
• People assessed as having a clinically significant risk of suicide, including those who score 4 or higher on a specific suicidal thinking scale in the past 6 months, or who have a lifetime history of suicidal behaviour.
• People with a history of substance use disorder within the past 12 months, those who drink more than 21 units of alcohol per week, or those who are unable to avoid alcohol for 48 hours before screening and each study visit.
• People currently taking certain types of antidepressants (such as MAO inhibitors, tricyclic antidepressants, bupropion, or mirtazapine), antipsychotic medications, or mood stabilisers.
• People who have used psilocybin or other psychedelic substances (such as LSD, ayahuasca, mescaline, or peyote) more than 10 times in the past 10 years, or any such substances within the 6 months before screening.
• People who have taken certain medications or supplements that could interact with psilocybin (such as buspirone or venlafaxine) in the 28 days before dosing — note that some SSRI antidepressants and certain sleep medications may still be permitted (confirm with trial site).
• People with a close family member (parent, sibling, or child) who has been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder type 1.
• People with a significant physical health condition affecting the nervous system, hormones, heart, lungs, digestive system, liver, or kidneys, as judged by the investigating doctor.
• People with a history of brain-related conditions such as epilepsy, seizures, raised pressure in the brain, brain bleeds, aneurysms, or brain tumours.
• People diagnosed with high blood pressure or irregular heart rhythm.
• People with a significantly elevated heart rate or blood pressure at screening, as measured by the study team.
• People with a clinically significant abnormality on a heart tracing (ECG) at screening.
• People with a specific ECG measurement (QTcF interval) above 450 milliseconds at screening.
• People with an underactive thyroid or abnormal thyroid blood test results at screening.
• People with significantly abnormal results on blood or urine tests, heart tracings, or physical examination at screening.
• People whose personal circumstances, behaviour, or current situation might make safe participation in the study difficult, as judged by the investigating doctor.
• People with any condition or history of surgery that could affect how the body processes the study medication.
• People with any other illness or condition that could interfere with the study or pose an unacceptable safety risk, as determined by the investigating doctor.
• People who test positive for drugs of abuse or alcohol at screening or on the first dosing day — a positive test for cannabis at screening may not automatically exclude someone, but the person must test negative on the dosing day and agree not to use cannabis during the study (confirm with trial site).
• People who consume very large amounts of caffeine or chocolate, as determined by the investigating doctor.
• People who have taken part in another clinical trial and received a medication or experimental substance within the 3 months before the first dose in this study.
• People with a known sensitivity or allergy to psilocybin or related compounds.
• People who have taken any medication known to inhibit a specific enzyme (monoamine oxidase) within 28 days before taking the study drug.
• People who have taken over-the-counter 5-HTP supplements or St John's Wort within 28 days before taking the study drug.
• People who have done vigorous exercise within 48 hours before any study visit or while at the study site.
• People capable of producing sperm who are unwilling to avoid sperm donation from the first dose until 3 months after the final dose.
• People who are currently pregnant, breastfeeding, or planning to become pregnant.

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