Phase 1 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:

• People who have experienced at least one mental health symptom in the past 30 days that has affected their ability to function in daily life, based on standardised assessments used by trained staff.
• People who are fluent in English and able to understand what the study involves, including its risks and benefits, and able to sign a consent form.
• People who agree to arrange safe travel home after the dosing session — either with a friend or family member, or via private transport arranged by the study team.
• People who can name a doctor or treating health professional who can be contacted by the research team to confirm it is safe for them to take part, and who agree to allow that contact.
• People who are able to swallow pills on the day of the dosing visit.
• People who can provide the name and contact details of a trusted adult (such as a relative, spouse, or close friend) who can be reached in an emergency, assist with transport if needed, and observe any changes in mood or behaviour after dosing.
• People who are found to be in good physical health based on a medical interview, physical examination, heart tracing (ECG), and routine blood and urine tests.
• People who are assessed as able to understand, reason through, and make decisions about their participation in the study.
• People whose mental health is considered stable, and whose current talking therapy (if any) has remained consistent for at least one month before the screening visit and is expected to continue unchanged throughout the study.
• People who are capable of becoming pregnant must agree to use effective contraception and not attempt to become pregnant from at least one month before the dosing session until at least one week after the final follow-up visit, and must return a negative pregnancy test at study entry and before dosing.

Who may not be able to join:

• People with a personal history of a primary psychotic disorder (such as schizophrenia or schizoaffective disorder) or Bipolar I disorder, or who have a parent, sibling, or child with any of these diagnoses.
• People who have had active thoughts of suicide with some intention to act on them within the past six months.
• People who have used classic psychedelics (such as LSD, psilocybin, DMT, or mescaline — not including microdosing) within the three months before enrolling.
• People who have used ketamine within one month before the screening visit.
• People with a history of using classic psychedelics more than ten times per year in structured, organised settings (such as retreats or ceremonies) over the past ten years (microdosing is not included in this).
• People with a history of a use disorder related to hallucinogenic substances.
• People who have had a bad or intolerant reaction to substances that significantly alter perception, such as psilocybin, LSD, or mescaline.
• People currently taking 5-hydroxytryptophan (5-HTP) or St. John's Wort.
• People who return a positive breathalyser test at screening.
• People who test positive on a urine drug screening for certain substances, with some exceptions as determined by the study team (confirm with trial site).
• People whose psychiatric medication or dosage has changed in the three months before enrolling.
• People who are currently taking, or have taken within the past two weeks, MAOIs, lithium, or methadone.
• People whose psychiatric condition makes it difficult to build a stable therapeutic relationship, based on patterns such as long-term relationship instability, significant stress-related paranoia, or identity disturbances.
• People who have taken part in another clinical drug trial within the 30 days before screening.
• People with a known allergy to gelatin.
• People with high blood pressure at screening, measured as above 140/90 mmHg.
• People with a history of heart disease, including conditions such as heart attack, heart failure, stroke, or significant heart rhythm problems.
• People whose heart tracing (ECG) at screening shows clinically significant abnormalities.
• People whose heart's electrical interval (QTcF) is above a certain threshold on their ECG, or where this measurement cannot be determined (confirm with trial site for specific values).
• People with certain risk factors for a serious heart rhythm problem called torsades de pointes, including a family history of sudden unexplained death or a condition called long QT syndrome.
• People with moderate to severe liver problems, based on specific blood test results (with an exception for a condition called Gilbert's syndrome).
• People who have taken certain blood vessel-narrowing medications or immune-modifying medications recently (confirm with trial site for specific timeframes and drug names).
• People with moderate to severe kidney problems, based on a specific blood test result.
• People with poorly controlled diabetes, based on a blood sugar marker above a certain level.
• People with significantly uncontrolled thyroid problems, unless their thyroid condition is being stably treated.
• People with any other health condition or finding that, in the opinion of the study doctor, could affect their safety or their ability to complete the study.

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