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:

• Women who identify as cisgender and are at least 18 years old.
• People who have been diagnosed with PTSD (post-traumatic stress disorder) caused by sexual assault, where the assault happened at least 6 months ago.
• People whose PTSD symptoms score 25 or higher on a standard clinical assessment called the CAPS-5 at the start of the study.
• People who are able to swallow pills.
• People who are willing to be driven home after the dosing session by a family member, caregiver, or trusted person.
• People who are able to complete all study assessments and attend all required visits without needing changes to the standard assessment tools.
• People who can read and speak English well.
• People who agree to have their clinic sessions recorded by audio and/or video (opting out of having those recordings analysed is allowed).
• People who agree to certain lifestyle rules around the dosing session, including eating only a light breakfast 2–3 hours before dosing, avoiding caffeine and nicotine for 2 hours before and 6 hours after dosing, avoiding alcohol for 24 hours before dosing, and not joining any other interventional clinical studies during the trial.
• People who agree not to start any new medications or new psychotherapy during the study.
• People who are already taking an SSRI antidepressant at a stable dose for 3 or more months before enrolling may be able to continue — though people taking MAOIs (a different type of antidepressant) would need to be gradually taken off them before the dosing session (confirm with trial site).
• People who are already in ongoing psychotherapy for more than 3 months at a stable level may be able to continue.
• People who have high blood pressure that is well managed with medication.
• People who have Hepatitis C with no active symptoms and who have already had it assessed and treated as needed.
• People who have an alcohol or substance use problem, as long as they are not currently in withdrawal or needing detox, and as long as the lead doctor agrees that a realistic plan is in place to reduce use during the study.
• People with a history of or current Type 2 diabetes, if further screening rules out heart or cardiovascular disease, the condition is considered stable and well managed, and the lead doctor approves.
• People with an underactive thyroid (hypothyroidism), if they are taking a stable and adequate dose of thyroid replacement medication.
• If a person could become pregnant, they would need to have a negative pregnancy test at the start of the study and before the dosing session, and agree to use effective birth control for 10 days after the dosing session if sexually active with a biologically male partner.

Who may not be able to join:

• People who are male.
• People who have a condition that affects their ability to swallow or absorb medication through the digestive system.
• People who are not able to provide informed consent.
• People who have had serious thoughts of suicide — specifically, thoughts with both intent and a plan — in the past 3 months.
• People whose current health or personal situation, in the opinion of the lead doctor, could interfere with safe participation.
• People who may pose a serious risk to others, as determined through a clinical interview and contact with their treating therapist.
• People with a history of or current diagnosis of schizophrenia, schizoaffective disorder, any psychotic disorder, major depressive disorder with psychotic features, bipolar disorder type 1, or certain personality disorders.
• People who need to take psychiatric medications that are not covered by the exceptions outlined in the study protocol (confirm with trial site).
• People who have had electroconvulsive therapy (ECT) within 12 weeks before enrolling.
• People who have had a stroke or heart attack within 6 months of signing the consent form, or a clinically significant heart rhythm problem within 1 year of signing the consent form.
• People with significant medical conditions affecting the blood, hormone system, brain, heart, lungs, kidneys, digestive system, immune system, or nervous system — including epilepsy or seizure disorders — that the investigator judges would increase the risk of receiving the study drug.
• People with uncontrolled high blood pressure (140/90 mmHg or higher).
• People with abnormal and clinically significant results on vital signs, heart trace (ECG), or blood/urine tests at screening.
• People with active liver disease causing symptoms.
• People who are pregnant, breastfeeding, or who could become pregnant and are not using effective birth control if sexually active with a biologically male partner.
• People who are known to be allergic or sensitive to any ingredient in the study drug.
• People who test positive for illicit or abused drugs on a urine screen before the dosing session (the lead investigator will review each case individually).
• People currently enrolled in another clinical drug or device trial, or who have participated in one within the past 30 days.
• People whose personal circumstances or behaviour are considered incompatible with safely participating in the study or completing study procedures — for example, being actively involved in legal proceedings related to the trial.

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