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 21 years of age or older
• People who are military veterans
• People who have provided written consent to take part in the trial
• People who are able to swallow pills
• People who have a confirmed diagnosis of Post-Traumatic Stress Disorder (PTSD) lasting at least 6 months, based on standard diagnostic guidelines (DSM-5)
• People whose PTSD symptoms score at least 28 on a standard clinical assessment tool called the CAPS-5
• People who are assessed by the study team as being at low immediate risk of suicide
• People who are currently receiving a stable type and frequency of talk therapy (unchanged for at least 2 months before screening and expected to stay the same throughout the study)
• People who are in stable general health, confirmed through an interview, medical questionnaire, physical exam, heart tracing (ECG), blood tests, and urine tests
• People who agree to consume roughly the same amount of caffeine they normally would on a typical morning before arriving at the research site on study drug days, or — if they do not normally drink caffeine — to avoid it on those days
• People who agree to avoid all mood- or mind-altering substances, including alcohol, for 24 hours before each drug session (caffeine and nicotine are exceptions to this rule)
• People who agree to avoid caffeine and nicotine for at least 2 hours before a dosing session begins
• People who agree not to take any medications taken only as needed (called PRN medications) on the mornings of drug sessions without the study team's approval
• People who agree to avoid sildenafil (Viagra), tadalafil, or similar medications for at least 72 hours before each drug session
• People who agree to stop taking any medications that block a specific brain receptor called 5HT2A, at least a sufficient amount of time before dosing to allow those medications to clear the body (confirm specific timeframe with trial site)
• People who agree, for one week before each drug session, to avoid non-prescription medications, nutritional supplements, and herbal supplements unless approved by the study team (common exceptions include paracetamol/acetaminophen, anti-inflammatory pain relievers, and standard doses of vitamins and minerals)
• People who have never used hallucinogenic substances that act on the serotonin 2A receptor (such as psilocybin) or MDMA at doses higher than what is typically defined as a "microdose"
• People who have at least a high school level of education or an equivalent qualification (such as a GED)
• People who weigh between 40 kg and 120 kg
• People who can provide a contact person — such as a relative, spouse, close friend, or other support person — who is willing and able to be reached by the study team in case of emergency
• People who agree to be accompanied home or to accommodation by a support person or study team member after each drug session
• People with Type 2 diabetes may be eligible if additional heart health screening is clear, the condition is well-managed and stable, and the study's Medical Monitor approves (confirm with trial site)
• People with an underactive thyroid (hypothyroidism) may be eligible if they are taking a stable and adequate thyroid replacement medication
• People with a history of or current glaucoma may be eligible if an eye specialist (ophthalmologist) approves their participation

Who may not be able to join:

• People who have ever been diagnosed with schizophrenia or a related psychotic disorder, or with Bipolar I or Bipolar II Disorder (conditions caused by a substance or another medical condition may be exceptions — confirm with trial site)
• People who currently have, or have had within the past year, a moderate or severe problem with alcohol or other drug use (tobacco, caffeine, and cannabis are excluded from this criterion)
• People who currently have, or have had within the past year, a diagnosis of Borderline Personality Disorder
• People who have had significant thoughts of suicide — such as with strong intent or a plan — in the past 6 months
• People who have a parent, sibling, or child with a diagnosis of schizophrenia, another psychotic disorder, or Bipolar I Disorder
• People whose nicotine dependence would make it impossible for them to go without nicotine for 8–10 hours on a dosing day
• People with a medical condition that would make it unsafe to receive MDMA or psilocybin, such as certain heart conditions, a history of dangerous overheating from drugs, or low blood sodium (confirm specifics with trial site)
• People who are currently taking daily medications — including herbal supplements — that affect the brain's serotonin system (such as antidepressants known as SSRIs or SNRIs, or MAOIs), or medications that affect how the liver processes certain drugs (such as bupropion)
• People currently taking certain specific medications including efavirenz, disulfiram (Antabuse), alcohol dehydrogenase inhibitors, or certain liver enzyme inhibitors such as phenytoin, regorafenib, or eltrombopag
• People whose dose of opioids, benzodiazepines, or other mood-altering or pain medications has changed in the 4 weeks before enrolment, or who cannot avoid taking these medications on drug session days
• People who are currently using illegal drugs, or who test positive for drugs or alcohol at screening or before any drug session
• People who have ever used a psychedelic substance such as MDMA or psilocybin at a dose higher than what is typically considered a "microdose"
• People with significantly elevated liver enzyme levels in blood tests (a sign the liver may not be functioning normally)
• People who are pregnant or breastfeeding
• Women of childbearing potential who are sexually active and do not agree to use a highly effective form of contraception (such as implants, injections, combined oral contraceptives, a progestin-releasing IUD, or a vasectomised partner) for the full duration of the study
• People with significant heart or blood vessel conditions, including coronary artery disease, stroke, angina, uncontrolled high blood pressure, a significant abnormal heart tracing (such as atrial fibrillation), a prolonged QT interval on ECG, heart valve problems, or a mini-stroke (TIA) within the past year
• People with a history of seizures or epilepsy involving seizures
• People with Type 1 diabetes
• People with a BMI below 18
• People who, in the study team's assessment, are likely to be re-exposed to the traumatic event or other serious trauma during daily life, or who lack social support or a stable place to live
• People who have received electroconvulsive therapy (ECT) within 12 weeks before enrolment
• People who have any medical history that could make receiving a drug that raises heart rate and blood pressure dangerous, including a history of heart attack, stroke, or aneurysm
• People with active liver disease or significantly elevated liver enzymes
• People with any other medical condition that the study investigator determines would meaningfully increase the risk of participating

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