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:

• People who are at least 18 years old.
• People who have been diagnosed with PTSD (according to standard diagnostic guidelines) where the diagnosis was made after 7 October 2023 and relates to events from that time onwards.
• People whose PTSD symptoms in the past month are rated as at least moderate, based on a standardised assessment score of 36 or higher, as measured by certified study coordinators.
• People who can speak and read Hebrew fluently.
• People who are able to swallow pills.
• People who were in psychotherapy before the study; if still in therapy during enrolment, they must agree to continue therapy throughout the study and allow the investigator to communicate with their therapist if needed.
• People who can provide contact details for a relative, spouse, close friend, or other support person who is willing to be contacted by the research team in case of an emergency.
• People who agree to inform the research team within 48 hours of any new medical conditions or procedures.
• People who agree to follow specific study requirements, including fasting and avoiding certain medications before experimental sessions, not joining other interventional clinical trials during the study, staying overnight at the study site after each experimental session and being driven home afterwards, and following all medication, therapy, and study procedures.
• People who can become pregnant must have a negative pregnancy test at the start of the study and before each experimental session, and must agree to use an approved form of birth control until 10 days after the last experimental session (confirm with trial site for full list of accepted methods).
• People who have a permanent home address for the next 6 months.
• People with well-controlled high blood pressure that is successfully managed with medication, provided additional heart health screening is passed.
• People with Hepatitis C virus (HCV) that causes no symptoms and has already been assessed and treated as needed.
• People with an alcohol or substance use problem, provided they are not currently in withdrawal or needing detox, and provided the investigator, therapy team, and study doctor agree on and approve a realistic plan to reduce use and manage symptoms.
• People with a history of, or current, Type 2 diabetes, provided additional heart health screening is passed, the condition is considered stable and well managed, and the study doctor gives approval.
• People with an underactive thyroid (hypothyroidism) who are on a stable and adequate thyroid replacement medication.
• People with a history of, or current, glaucoma, provided an eye specialist (ophthalmologist) gives approval for participation.

Who may not be able to join:

• People who are not able to give proper informed consent to participate.
• People who have a known sensitivity or allergy to any of the study treatments or their components, or any other allergy that the investigator believes makes participation unsafe.
• People who are expected to be on active military duty in the next 12 months.
• People who have lost a close person within the past 6 months.
• People who have received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or ketamine therapy within 12 weeks before enrolling.
• People who have a current or past diagnosis of schizophrenia, schizoaffective disorder, major depression with psychotic features, a psychotic disorder, bipolar disorder type I or II, or dissociative identity disorder.
• People who currently have a substance use disorder (other than caffeine or nicotine use) that the research team judges to be a safety concern or likely to interfere with the study, or who are unable or unwilling to agree to a plan to reduce use.
• People who have had an active illicit drug (other than cannabis) or prescription drug use disorder at any level of severity within the 12 months before enrolment.
• People who currently have a diagnosed personality disorder from Cluster A (such as paranoid, schizoid, or schizotypal), Cluster B (such as antisocial, borderline, histrionic, or narcissistic), or Cluster C (such as avoidant, dependent, or obsessive-compulsive), as assessed by a structured clinical interview.
• People who are currently assessed as having a serious risk of suicide, including those who score at or above certain thresholds on a standardised suicide risk assessment in the past 6 months, or who are judged likely to need hospitalisation related to suicidal thoughts or behaviour; note that a past history of suicide attempts is not automatically an exclusion (confirm with trial site).
• People who are considered to present a serious risk of harm to others, as determined through clinical interview and contact with their treating psychiatrist.
• People who have a significant fear of blood or needles that would prevent required blood tests from being done.
• People who, to their knowledge, have an immediate family member diagnosed with a psychotic disorder.
• People who have a medical history of conditions that could make receiving a drug that raises blood pressure and heart rate harmful, including prior heart attack, stroke, or aneurysm.
• People who have uncontrolled high blood pressure, defined as readings of 140/90 mmHg or higher recorded on three separate occasions.
• People who have a history of a serious irregular heartbeat (ventricular arrhythmia), other than a specific minor type (premature ventricular contractions without ischaemic heart disease).
• People who have Wolff-Parkinson-White syndrome or a similar heart conduction abnormality that has not been successfully treated.
• People who have had a significant heart rhythm problem within the 12 months before screening, unless it was successfully treated with a procedure called ablation, with no recurrence for at least one year off all relevant medications, confirmed by a heart specialist.
• People who show a significantly prolonged heart electrical interval (QTc) on testing — above 450 milliseconds for males and 460 milliseconds for females (confirm with trial site for details relating to transgender or non-binary participants).
• People who have additional risk factors for a specific dangerous heart rhythm disorder called Torsade de Pointes, such as heart failure, low potassium levels, or a family history of Long QT Syndrome.
• People who need to take medications during experimental sessions that are known to prolong the QTc heart interval (confirm with trial site for specific medications).
• People who have symptomatic liver disease or significantly elevated liver enzyme levels.
• People who have a history of dangerously low sodium levels (hyponatremia) or dangerously high body temperature (hyperthermia).
• People who weigh less than 48 kilograms.
• People who have had ketamine-assisted therapy or used ketamine within 12 weeks before enrolling.

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