Phase 1 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 are at least T+H years old and under 89 years old (confirm with trial site — the lower age limit appears incomplete in the source document)
• People who identify as a veteran, first responder, female survivor of sexual violence, or Indigenous person
• People who are not currently pregnant, not planning to become pregnant, and not breastfeeding; if pregnancy is possible, people willing to use a reliable form of birth control for the whole study
• People who are able and willing to gradually stop taking any medications that might interfere with how psilocybin works, if the trial team determines this is necessary
• People who can read, speak, and understand English
• People who are able and willing to agree to the study terms, including attending all trial visits (most in a group setting), preparation and follow-up sessions, and completing all assessments
• People who are able and willing to swallow capsules
• People who have been diagnosed with PTSD as defined by the DSM-5 clinical guidelines
• People whose PTSD symptoms are moderate to severe (a score of 34 or higher on the PCL-5 questionnaire) and have been present for at least six months

Who may not be able to join:

• People who are unable to go without alcohol, non-prescribed opioids, methamphetamines, cocaine, benzodiazepines, or other illicit substances for at least five days
• People who are unable or unwilling to stop using cannabis for 24 hours before a psilocybin dosing session and for 12 hours after receiving the dose
• People at risk of significant withdrawal symptoms from any substance on the day of dosing
• People who are currently pregnant or breastfeeding
• People with uncontrolled high blood pressure (above 140/90 at screening, or above 145/95 on dosing day, measured three times in a row)
• People with a history of heart attack, cardiac ischemia, heart failure, significant heart valve disease, or pulmonary hypertension, or any other significant heart condition the trial doctor considers a concern
• People with a clinically significant abnormal heart rhythm reading on an ECG, including a prolonged QT interval (over 450 milliseconds for males or over 470 milliseconds for females)
• People with poorly controlled diabetes (HbA1c above 8.0%) or significant low blood sugar episodes in the past six months
• People with epilepsy or another seizure disorder, a neurodegenerative condition (such as dementia, Parkinson's disease, Huntington's disease, or ALS), or a brain tumour
• People with serious abnormalities in blood count or chemistry tests, severe liver impairment, severe kidney impairment, or an unstable thyroid condition
• People with active thoughts of suicide, or who have been hospitalised for a suicide attempt in the 12 months before screening, or who give certain affirmative responses on a standard suicide assessment tool (C-SSRS questions 4 or 5)
• People with a confirmed diagnosis of schizophrenia or another psychotic disorder, or who have a parent or sibling with schizophrenia
• People with an Axis-II diagnosis (a category of certain personality and developmental conditions — confirm with trial site)
• People who have had a full psychedelic experience using substances such as psilocybin, mescaline, ayahuasca, DMT, LSD, MDMA, or ketamine in the past six months (note: very low-dose "microdosing" use below specified thresholds for fewer than 30 days per year is not automatically excluded, but all participants must agree to stop using psychedelics from the time of screening onwards)
• People returning to an unsafe living environment or who lack adequate social support
• People with any other physical or psychological condition, medication use, or other finding that the trial team determines would make participation unsuitable
• People who have taken part in experimental PTSD treatment or any other research study within 30 days of their screening assessment

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