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 aged 18 years or older
• People who have been diagnosed with Post-Traumatic Stress Disorder (PTSD) for at least 6 months, confirmed by a study psychiatrist using standard diagnostic tools, with at least one identified traumatic event and a score of 33 or higher on a standard PTSD symptom checklist
• People who are willing and able to sign a consent form agreeing to the study's requirements
• People who are willing to take the study drug themselves, complete quality-of-life questionnaires, and attend all required study visits
• People who are able to rate their average pain level over the past week using a standard pain scale
• People whose kidney function meets acceptable levels, as confirmed by blood tests at screening and on the first study day (confirm with trial site for specific thresholds)
• People whose liver function meets acceptable levels, as confirmed by blood tests showing liver enzyme levels within an acceptable range at screening and on the first study day
• People who agree to only use the psilocybin mushroom supplied by the trial site, and to avoid all other psilocybin or similar substances for at least 30 days before and 30 days after receiving the study drug
• People who are willing to wear a health-tracking wearable device every day during sleep and daily activity, charge it twice a week, and sync it daily throughout the study
• People who agree to avoid alcohol, cannabis, certain medications (including antidepressants such as SSRIs, SNRIs, and MAO inhibitors), and other non-routine medications for at least 24 hours before the study drug is given (daily caffeine, nicotine, and opioid pain medication are exceptions)
• People who are on a stable medication or therapy routine before joining, who agree to inform their current healthcare providers about their participation, and who agree to report any changes in their medications or therapy to study staff during the study
• Women who could become pregnant must have a negative pregnancy test at screening and on the first study day, must use highly effective birth control for 30 days after treatment, and must not be trying to become pregnant or breastfeeding during that period (acceptable birth control methods include IUDs, hormonal implants or injections, or two forms of barrier contraception used together — confirm with trial site)
• People who can read and write English well enough to communicate effectively with study staff
• People who agree not to join any other interventional clinical trials while participating in this study

Who may not be able to join:

• People with uncontrolled high blood pressure (above 140/90 at screening, or above 145/95 on the first study day)
• People who have had a seizure within the past 3 months
• People with a history of stroke or transient ischemic attacks (mini-strokes)
• People with a pre-existing history of heart valve problems or high blood pressure in the lungs
• People with a significantly prolonged heart rhythm measurement (QT interval of 450 milliseconds or more) detected across three heart-tracing tests taken within a short period
• People with uncontrolled diabetes, indicated by a blood sugar control marker above a certain level (confirm with trial site)
• People who are taking certain medications that act on the brain's serotonin system within 24 hours before, or up to 72 hours after, the study drug is given, due to the risk of harmful drug interactions
• People who have had serious thoughts of suicide (at a significant level) in the past 6 months, or any suicidal behaviour in the past 12 months, as assessed using a standard rating scale
• People with severe anxiety (scoring 15 or above on a standard anxiety scale) or severe depression (scoring 20 or above on a standard depression scale)
• People who are pregnant, breastfeeding, or capable of becoming pregnant and not using highly effective contraception
• People who have a known allergy or medical reason not to take psilocybin mushrooms
• People who have used psilocybin, LSD, DMT, Ayahuasca, Peyote, mescaline, or ketamine in the past 30 days, unless use of these substances is stopped at least 30 days before the first study day and the person agrees not to use them for 30 days after
• People who are unable to attend in-person visits at the study site, or who plan to move away from the area before the 3-month follow-up visit
• People who, in the judgement of the study investigator or medical monitor, have any condition that could interfere with their participation or affect the assessment of the study drug's safety or effectiveness

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