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New treatment option for Post Traumatic Stress Disorder
Official title Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD
ClinicalTrials.gov ID: NCT06386003
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, being studied as a potential treatment for post traumatic stress disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study...
- Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms;
- Are willing to refrain from taking any psychiatric medications during the study period.
You likely can't join if
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
- Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder...
- Have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any...
- Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions;
- History of seizure disorder;
- Uncontrolled insulin-dependent diabetes;
See the full eligibility criteria
- Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study psychiatrist;
- Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms;
- Are willing to refrain from taking any psychiatric medications during the study period.
- Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
- Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder, schizoaffective disorder, bipolar disorder or, dissociative identity disorder;
- Have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly...
- Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions;
- History of seizure disorder;
- Uncontrolled insulin-dependent diabetes;
- Recent stroke, intracranial or subarachnoid hemorrhage (\< 1 year from signing of informed consent form [ICF]), recent myocardial infarction (\< 1 year from signing of ICF), clinically significant arrhythmia (\< 1 year...
- Have liver disease with the exception of asymptomatic people with Hepatitis C who have previously undergone evaluation and successful treatment;
- Lifetime history of substance-induced psychosis;
- Lifetime history of substance use disorder with a hallucinogen;
- History of alcohol use disorder in the past 3 months.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.